Sacituzumab Govitecan in Hormone Receptor–Positive/Human Epidermal Growth Factor Receptor 2–Negative Metastatic Breast Cancer

Hope S. Rugo, MD; Aditya Bardia, MD, MPH; Frederik Marmé, MD, PhD; Javier Cortes, MD, PhD; Peter Schmid, MD, PhD; Delphine Loirat, MD, PhD; Olivier Trédan, MD, PhD; Eva Ciruelos, MD, PhD; Florence Dalenc, MD, PhD; Patricia Gómez Pardo, MD; Komal L. Jhaveri, MD; Rosemary Delaney, MPH; Olivia Fu, MD; Lanjia Lin, PhD; Wendy Verret, PhD; Sara M. Tolaney, MD, MPH

Disclosures

J Clin Oncol. 2022;40(29):3365-3376.

Abstract and Introduction

Abstract

Purpose: Hormone receptor–positive (HR+) human epidermal growth factor receptor 2–negative (HER2–) endocrine-resistant metastatic breast cancer is treated with sequential single-agent chemotherapy with poor outcomes. Sacituzumab govitecan (SG) is a first-in-class antibody-drug conjugate with an SN-38 payload targeting trophoblast cell-surface antigen 2, an epithelial antigen expressed in breast cancer.

Methods: In this global, randomized, phase III study, SG was compared with physician's choice chemotherapy (eribulin, vinorelbine, capecitabine, or gemcitabine) in endocrine-resistant, chemotherapy-treated HR+/HER2– locally recurrent inoperable or metastatic breast cancer. The primary end point was progression-free survival (PFS) by blinded independent central review.

Results: Patients were randomly assigned to receive SG (n = 272) or chemotherapy (n = 271). The median age was 56 years, 95% had visceral metastases, and 99% had a prior cyclin-dependent kinase 4/6 inhibitor, with three median lines of chemotherapy for advanced disease. Primary end point was met with a 34% reduction in risk of progression or death (hazard ratio, 0.66 [95% CI, 0.53 to 0.83; P = .0003]). The median PFS was 5.5 months (95% CI, 4.2 to 7.0) with SG and 4.0 months (95% CI, 3.1 to 4.4) with chemotherapy; the PFS at 6 and 12 months was 46% (95% CI, 39 to 53) v 30% (95% CI, 24 to 37) and 21% (95% CI, 15 to 28) v 7% (95% CI, 3 to 14), respectively. Median overall survival (first planned interim analysis) was not yet mature (hazard ratio, 0.84; P = .14). Key grade ≥ 3 treatment-related adverse events (SG v chemotherapy) were neutropenia (51% v 38%) and diarrhea (9% v 1%).

Conclusion: SG demonstrated statistically significant PFS benefit over chemotherapy, with a manageable safety profile in patients with heavily pretreated, endocrine-resistant HR+/HER2– advanced breast cancer and limited treatment options.

Introduction

Although endocrine therapy combined with cyclin-dependent kinase 4/6 inhibitors (CDK4/6i) has extended overall survival (OS) for metastatic hormone receptor–positive (HR+) human epidermal growth factor receptor 2–negative (HER2–) breast cancer to over 5 years in the first-line setting^[1–5] and combinations with phosphoinositide 3-kinase or mammalian target of rapamycin inhibitors offer benefit in subsequent treatment lines,^[6] endocrine resistance eventually develops. Sequential single-agent chemotherapy is the next therapeutic option but is associated with declining response rates and disease control and increased toxicity.^[6–10]

Sacituzumab govitecan (SG) is a first-in-class trophoblast cell-surface antigen 2 (Trop-2)–directed antibody-drug conjugate (ADC), consisting of a humanized anti–Trop-2 monoclonal antibody conjugated to the active metabolite of irinotecan, SN-38,^[11] via a hydrolyzable CL2A linker.^[12] Trop-2 is a transmembrane calcium signal transducer highly expressed in solid tumors, especially HR+/HER2– and triple-negative breast cancers (with a prevalence of > 90%), and linked to tumor progression and poor prognosis.^[13–15] Internalization of Trop-2–bound SG delivers SN-38 into the tumor cell through hydrolysis of the linker.^[16] Because SN-38 is a membrane-permeable free molecule released in the tumor microenvironment, it may elicit antitumor effects in adjacent non–Trop-2-expressing tumor cells (bystander effect).^[16]

SG received full authorization from the Food and Drug Administration and European Medicines Agency for patients with metastatic triple-negative breast cancer who had received at least two prior chemotherapies (at least one for metastatic disease) and has accelerated approval for locally advanced or metastatic urothelial cancer.^[17–19] In the phase I/II IMMU-132-01 basket study, SG showed encouraging activity and safety in 54 patients with HR+/HER2– metastatic breast cancer (MBC) who progressed on at least one line of endocrine therapy and at least one prior chemotherapy in the metastatic setting.^[20] The objective response rate was 31.5%, and the median progression-free survival (PFS) and OS were 5.5 and 12 months, respectively (CDK4/6i-pretreated group, 25%, 3.8 and 11 months).

Here, we provide the primary results of TROPiCS-02, a global, randomized, open-label, multicenter phase III study of SG versus single-agent chemotherapy in patients with locally recurrent inoperable or metastatic HR+/HER2– breast cancer (Data Supplement, online only).

1 2 3 4

Next Section

Table 1. Baseline Characteristics and Treatment History of Patients
Characteristic	SG (n = 272)	Chemotherapy (n = 271)	All (N = 543)
Female, No. (%)	270 (99)	268 (99)	538 (99)
Median age, years (range)	57 (29–86)	55 (27–78)	56 (27–86)
Race or ethnic group, No. (%)
White	184 (68)	178 (66)	362 (67)
Black	8 (3)	13 (5)	21 (4)
Asian	11 (4)	5 (2)	16 (3)
Others^a	0	5 (2)	5 (1)
Not specified^b	69 (25)	70 (26)	139 (26)
ECOG PS, No. (%)
0	116 (43)	126 (46)	242 (45)
1	156 (57)	145 (54)	301 (55)
Visceral metastases at baseline, No. (%)	259 (95)	258 (95)	517 (95)
Liver metastases,^c No. (%)	229 (84)	237 (87)	466 (86)
De novo MBC, No. (%)	78 (29)	60 (22)	138 (25)
Median time from initial metastatic diagnosis to random assignment, months (range)	48.5 (1.2–243.8)	46.6 (3.0–248.8)	47.8 (1.2–248.8)
Prior chemotherapy in the (neo)adjuvant setting, No. (%)	173 (64)	184 (68)	357 (66)
Prior endocrine therapy in the metastatic setting > 6 months, No. (%)
Yes	235 (86)	234 (86)	469 (86)
No	37 (14)	37 (14)	74 (14)
Prior CDK4/6i use, months, No. (%)
≤ 12	161 (59)	166 (61)	327 (60)
> 12	106 (39)	102 (38)	208 (38)
Unknown	5 (2)	3 (1)	8 (1)
Median prior chemotherapy regimens in the metastatic setting, No. (%)^d	3 (0–8)^d	3 (1–5)^d	3 (0–8)^d
0	1 (< 1)	0	1 (< 1)
1	8 (3)	2 (1)	10 (2)
2	104 (38)	118 (43)	222 (41)
≥ 3	159 (58)	151 (56)	310 (57)
Median prior chemotherapy regimens, No. (range)	4 (1–9)	4 (2–7)	4 (1–9)
Median prior anticancer regimens,^e No. (range)	7 (3–17)	7 (3–16)	7 (3–17)
Setting of prior anticancer regimens,^e No. (%)
Neoadjuvant	67 (25)	62 (23)	129 (24)
Adjuvant	186 (68)	206 (76)	392 (72)
Advanced/metastatic	272 (100)	271 (100)	543 (100)
Others/unknown	12 (4)	9 (3)	21 (4)
Most common prior anticancer therapy,^e No. (%)
Palbociclib	238 (88)	228 (84)	466 (86)
Capecitabine	226 (83)	234 (86)	460 (85)
Fulvestrant	235 (86)	223 (82)	458 (84)
Cyclophosphamide	204 (75)	209 (77)	413 (76)
Paclitaxel	210 (77)	196 (72)	406 (75)
Letrozole	185 (68)	210 (77)	395 (73)
Tamoxifen	160 (59)	165 (61)	325 (60)
Doxorubicin^e	149 (55)	134 (49)	283 (52)
Exemestane	142 (52)	134 (49)	276 (51)
Everolimus	117 (43)	115 (42)	232 (43)
Docetaxel	106 (39)	120 (44)	226 (42)
Eribulin^e	97 (36)	97 (36)	194 (36)
Anastrozole	87 (32)	69 (25)	156 (29)
Epirubicin	78 (29)	94 (35)	172 (32)
Fluorouracil	66 (24)	77 (28)	143 (26)
Most common prior anticancer therapy class in the metastatic setting,^e No. (%)
Endocrine therapy	268 (99)	269 (99)	537 (99)
CDK4/6i	267 (98)	270 (> 99)	537 (99)
Targeted agent	181 (67)	172 (63)	353 (65)
Immunotherapy	21 (8)	15 (6)	36 (7)
Chemotherapy	271 (> 99)	271(100)	542 (> 99)
Most common prior chemotherapy agent in the metastatic setting,^e No. (%)
Capecitabine	221 (81)	232 (86)	453 (83)
Paclitaxel	174 (64)	147 (54)	321 (59)
Eribulin^e	95 (35)	88 (33)	183 (34)
ER expression, No. (%)^f
< 1%	2 (1)	5 (2)	7 (1)
1%-10%	12 (4)	15 (6)	27 (5)
> 10%	258 (95)	246 (91)	504 (93)
Unknown	0	5 (2)	5 (1)
PR expression, No. (%)^f
< 1%	103 (38)	101 (37)	204 (38)
1%-10%	45 (17)	44 (16)	89 (16)
> 10%	124 (46)	120 (44)	244 (45)
Unknown	0	6 (2)	6 (1)

Abbreviations: CDK4/6i, cyclin-dependent kinase 4/6 inhibitor; ECOG PS, Eastern Cooperative Oncology Group performance status; ER, estrogen receptor; MBC, metastatic breast cancer; PR, progesterone receptor; SG, sacituzumab govitecan.
^aIncludes American Indian or Alaska Native, Native Hawaiian or other Pacific Islander.
^bNot reported indicates local regulators who did not allow collection of race or ethnicity information.
^cPresence of baseline target/nontarget liver lesion per RECIST1.1 by local investigator review.
^dThe reported number of prior therapies was miscounted at screening for some patients. Nine patients had fewer or more prior chemotherapy regimens in the metastatic setting than the specified inclusion criteria and were included in the intention-to-treat population.
^eAnticancer regimens refer to any treatment regimen that was used to treat breast cancer in any setting and includes endocrine therapy and everolimus. Eribulin includes the preferred drug name eribulin and eribulin mesylate. Doxorubicin includes the preferred drug name doxorubicin, pegylated liposomal doxorubicin hydrochloride, liposomal doxorubicin, doxorubicin hydrochloride, liposomal doxorubicin hydrochloride, and pegylated liposomal doxorubicin.
^fPer protocol, hormone receptor status was to be documented from locally recurrent or metastatic sites and the few cases that did not have protocol deviations.

Table 2. Summary of Treatment Efficacy (per blinded independent central review)
Efficacy Outcome	SG (n = 272)	Chemotherapy (n = 271)
Median PFS, months (95% CI),	5.5 (4.2 to 7.0)	4.0 (3.1 to 4.4)
HR; P (95% CI)	0.66 (0.53 to 0.83); P = .0003
PFS rate, %, months (95% CI)
6	46 (39 to 53)	30 (24 to 37)
12	21 (15 to 28)	7 (3 to 14)
Median OS, months (95% CI)	13.9 (12.7 to 15.4)	12.3 (10.8 to 14.2)
HR; P (95% CI)	0.84 (0.67 to 1.06); P = .14
Objective response rate, No. (%)	57 (21)	38 (14)
Best overall response, No. (%)
Complete response	2 (1)	0
Partial response	55 (20)	38 (14)
Stable disease	142 (52)	106 (39)
Stable disease ≥ 6 months	35 (13)	21 (8)
Progressive disease	58 (21)	76 (28)
Not evaluable	15 (6)	51 (19)
CBR,^a No. (%)	92 (34)	59 (22)
Median DOR, months (95% CI)	7.4 (6.5 to 8.6)	5.6 (3.8 to 7.9)

Abbreviations: CBR, clinical benefit rate; DOR, duration of response; HR, hazard ratio; OS, overall survival; PFS, progression-free survival; SG, sacituzumab govitecan.
^aCBR is defined as the percentage of patients with a confirmed best overall response of complete response, partial response, and stable disease ≥ 6 months.

Table 3. Summary of Treatment-Related AEs of Any Grade (≥ 10%) and Worst Grade 2 or Grade ≥ 3 (≥ 5%) in the Safety Population (all patients who received ≥ 1 dose of study treatment)
Treatment-Related AE^a	SG (n = 268)			Chemotherapy (n = 249)
Treatment-Related AE^a	All Grade	Grade 2	Grade ≥ 3	All Grade	Grade 2	Grade ≥ 3
Hematologic, No. (%)
Neutropenia^b	188 (70)	45 (17)	136 (51)	134 (54)	29 (12)	94 (38)
Anemia^c	91 (34)	44 (16)	17 (6)	62 (25)	31 (12)	8 (3)
Leukopenia^d	37 (14)	7 (3)	23 (9)	23 (9)	8 (3)	13 (5)
Lymphopenia^e	31 (12)	11 (4)	10 (4)	25 (10)	7 (3)	8 (3)
Febrile neutropenia	14 (5)	0	14 (5)	11 (4)	0	11 (4)
GI, No. (%)
Diarrhea	152 (57)	56 (21)	25 (9)	41 (16)	12 (5)	3 (1)
Nausea	148 (55)	56 (21)	3 (1)	77 (31)	23 (9)	7 (3)
Vomiting	50 (19)	12 (4)	1 (< 1)	30 (12)	8 (3)	4 (2)
Constipation	49 (18)	8 (3)	0	36 (14)	8 (3)	0
Abdominal pain	34 (13)	12 (4)	2 (1)	17 (7)	4 (2)	0
Others, No. (%)
Alopecia	123 (46)	105 (39)	0	41 (16)	18 (7)	0
Fatigue	100 (37)	37 (14)	15 (6)	73 (29)	31 (12)	6 (2)
Asthenia	53 (20)	26 (10)	5 (2)	37 (15)	19 (8)	2 (1)
Decreased appetite	41 (15)	9 (3)	1 (< 1)	34 (14)	13 (5)	1 (< 1)
Neuropathy^f	23 (9)	8 (3)	3 (1)	38 (15)	16 (6)	6 (2)

NOTE. Assessed in the safety population.
Abbreviations: AE, adverse event; SG, sacituzumab govitecan.
^aPatients may report more than one event per preferred term. AEs were coded using Medical Dictionary for Regulatory Activities v24.0, and AE severity was graded per National Cancer Institute Common Terminology Criteria for Adverse Events v5.0.
^bCombined preferred terms of neutropenia and neutrophil count decreased.
^cCombined preferred terms of anemia, hemoglobin decreased, and red blood cell count decreased.
^dCombined preferred terms of leukopenia and WBC count decreased.
^eCombined preferred terms of lymphopenia and lymphocyte count decreased.
^fCombined preferred terms of gait disturbance, hypoesthesia, muscular weakness, neuropathy peripheral, paresthesia, and peripheral sensory neuropathy.

Authors and Disclosures

Hope S. Rugo, MD¹, Aditya Bardia, MD, MPH², Frederik Marmé, MD, PhD³, Javier Cortes, MD, PhD^4,5, Peter Schmid, MD, PhD⁶, Delphine Loirat, MD, PhD⁷, Olivier Trédan, MD, PhD⁸, Eva Ciruelos, MD, PhD⁹, Florence Dalenc, MD, PhD¹⁰, Patricia Gómez Pardo, MD¹¹, Komal L. Jhaveri, MD¹², Rosemary Delaney, MPH¹³, Olivia Fu, MD¹⁴, Lanjia Lin, PhD¹⁵, Wendy Verret, PhD¹³ and Sara M. Tolaney, MD, MPH¹⁶, on behalf of the TROPiCS-02 Study Investigators

¹Department of Medicine, University of California San Francisco Helen Diller Family Comprehensive Cancer Center, San Francisco, CA
²Medical Oncology, Massachusetts General Hospital Cancer Center, Harvard Medical School, Boston, MA
³Medical Faculty Mannheim, Heidelberg University, University Hospital Mannheim, Heidelberg, Germany
⁴Medical Oncology Department, International Breast Cancer Center, Pangaea Oncology, Quironsalud Group, Madrid and Barcelona, Spain
⁵Faculty of Biomedical and Health Sciences, Department of Medicine, Universidad Europea de Madrid, Madrid, Spain
⁶Barts Cancer Institute, Queen Mary University of London, London, United Kingdom
⁷Medical Oncology Department and D3i, Institut Curie, Paris, France
⁸Medical Oncology Department, Centre Léon Bérard, Lyon, France
⁹Medical Oncology, Hospital Universitario 12 de Octubre, Madrid, Spain
¹⁰Institut Claudius Regaud, IUCT-Oncopole, Toulouse, France
¹¹Hospital Universitari Vall D'Hebron, Barcelona, Spain
¹²Memorial Sloan-Kettering Cancer Center, New York, N
¹³Department of Clinical Development, Gilead Sciences Inc, Foster City, CA
¹⁴Department of Global Patient Safety, Gilead Sciences Inc, Foster City, CA
¹⁵Department of Biostatistics, Gilead Sciences Inc, Foster City, CA
¹⁶Department of Medical Oncology, Dana-Farber Cancer Institute, Boston, MA

Corresponding Author
Hope S. Rugo, MD, University of California San Francisco Helen Diller Family Comprehensive Cancer Center, 1825 4th St, San Francisco, CA 94158; e-mail: Hope.Rugo@ucsf.edu.

Authors' Disclosures of Potential Conflicts of Interest
Disclosures provided by the authors are available with this article at DOI https://doi.org/10.1200/JCO.22.01002.

Sacituzumab Govitecan in Hormone Receptor–Positive/Human Epidermal Growth Factor Receptor 2–Negative Metastatic Breast Cancer
The following represents disclosure information provided by authors of this manuscript. All relationships are considered compensated unless otherwise noted. Relationships are self-held unless noted. I 5 Immediate Family Member, Inst 5 My Institution. Relationships may not relate to the subject matter of this manuscript. For more information about ASCO's conflict of interest policy, please refer to www.asco.org/rwc or ascopubs.org/jco/authors/author-center.
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Hope S. Rugo
Honoraria: Puma Biotechnology, Mylan, Samsung Bioepis, Chugai Pharma, Blueprint Medicines, Napo Pharmaceuticals
Research Funding: OBI Pharma (Inst), Pfizer (Inst), Novartis (Inst), Lilly (Inst), Genentech (Inst), Merck (Inst), Odonate Therapeutics (Inst), Daiichi Sankyo (Inst), Sermonix Pharmaceuticals (Inst), AstraZeneca (Inst), Gilead Sciences (Inst), Ayala Pharmaceuticals (Inst), Astellas Pharma (Inst), Seattle Genetics (Inst), MacroGenics (Inst), Boehringer Ingelheim (Inst), Polyphor (Inst)
Open Payments Link: https://openpaymentsdata.cms.gov/summary

Aditya Bardia
Consulting or Advisory Role: Novartis (Inst), Genentech, Pfizer, Spectrum Pharmaceuticals, BioTheranostics, Merck, Radius Health (Inst),
Immunomedics (Inst), Genentech/Roche (Inst), Pfizer (Inst), Innocrin Pharma (Inst), Sanofi, Puma Biotechnology, Daiichi Sankyo/AstraZeneca, Foundation Medicine, Philips Healthcare
Research Funding: Genentech (Inst), Novartis (Inst), Pfizer (Inst), Merck (Inst), Sanofi (Inst), Radius Health (Inst), Immunomedics (Inst), AstraZeneca/Daiichi Sankyo (Inst)
Open Payments Link: https://openpaymentsdata.cms.gov/physician/523675

Frederik Marmé
Honoraria: Roche/Genentech, Novartis, Pfizer, AstraZeneca, Tesaro, Clovis Oncology, Eisai, Celgene, Genomic Health, PharmaMar, Amgen, MSD Oncology, Immunomedics (Inst), Settle Genetics, Myriad Genetics, Pierre Fabre, GlaxoSmithKline, AGENDIA, Lilly, Gilead Sciences
Consulting or Advisory Role: AstraZeneca (Inst), Tesaro, Pfizer, Roche (Inst), Genomic Health, CureVac, Amgen, Vaccibody (Inst), Immunomedics (Inst), Eisai, GlaxoSmithKline, Gilead Sciences
Research Funding: Roche/Genentech (Inst), Novartis (Inst), AstraZeneca (Inst), Tesaro (Inst), Clovis Oncology (Inst), MSD Oncology (Inst), Vaccibody (Inst), Gilead Sciences (Inst), GlaxoSmithKline (Inst)
Travel, Accommodations, Expenses: Roche, Pfizer, AstraZeneca

Javier Cortes
Stock and Other Ownership Interests: MedSIR, Nektar, Leuko (I)
Honoraria: Novartis, Eisai, Celgene, Pfizer, Roche, Samsung, Lilly, Merck Sharp & Dohme, Daiichi Sankyo
Consulting or Advisory Role: Celgene, Cellestia Biotech, AstraZeneca, Roche, Settle Genetics, Daiichi Sankyo, ERYTECH Pharma, Polyphor, Athenex, Lilly, Servier, Merck Sharp & Dohme, GlaxoSmithKline, Leuko, Clovis Oncology, Bioasis, Boehringer Ingelheim, Ellipses Pharma, HiberCell, BioInvent, GEMoaB, Gilead Sciences, Menarini, Zymeworks, Reveal Genomics
Research Funding: ARIAD (Inst), AstraZeneca (Inst), Baxalta (Inst), Bayer (Inst), Eisai (Inst), Guardant Health (Inst), Merck Sharp & Dohme (Inst), Pfizer (Inst), Puma Biotechnology (Inst), Queen Mary University of London (Inst), Roche (Inst), Piqur (Inst)
Patents, Royalties, Other Intellectual Property: Pharmaceuticals Combinations of A Pi3k Inhibitor and a Microtubule Destabilizing Agent. Javier Cortes Castan, Alejandro Piris Gimenez, Violeta Srra Elizalde. WO 2014/199294 A, Her2 as a predictor of response to dual HER2 blockade in the absence of cytotoxic therapy, Aleix Prat, Antonio Llombart, Javier Cortes, US 2019/0338368 A1
Travel, Accommodations, Expenses: Roche, Pfizer, Eisai, Novartis, Daiichi Sankyo, Gilead Sciences

Peter Schmid
Employment: Roche (I)
Honoraria: AstraZeneca, Bayer, Boehringer Ingelheim, Merck, Novartis, Pfizer, Puma Biotechnology, Roche, Eisai, Celgene
Consulting or Advisory Role: Genentech/Roche (I), AstraZeneca, Merck, Boehringer Ingelheim, Bayer, Pfizer, Novartis, Eisai, Celgene, Puma Biotechnology
Research Funding: AstraZeneca (Inst), Astellas Pharma (Inst), OncoGenex (Inst), Genetech (Inst), Novartis (Inst), Roche (Inst), Medivation

Delphine Loirat
Honoraria: MSD, Gilead Sciences, AstraZeneca, Lilly
Consulting or Advisory Role: Roche, MSD Oncology, AstraZeneca, Novartis, Pfizer, Immunomedics, Gilead Sciences, 4D Pharma, Lilly
Travel, Accommodations, Expenses: Roche, AstraZeneca, MSD, Pfizer, Gilead Sciences

Olivier Trédan
Consulting or Advisory Role: Roche, Pfizer, Lilly, AstraZeneca, MSD Oncology, Daiichi Sankyo Europe GmbH, Eisai Europe, Sandoz-Novartis, Seattle Genetics, Pierre Fabre, Gilead Sciences
Research Funding: Roche (Inst), Bristol Myers Squibb (Inst), MSD Oncology (Inst), AstraZeneca (Inst), Novartis (Inst), Bayer (Inst),
Travel, Accommodations, Expenses: Roche, Novartis, Pfizer, Lilly, AstraZeneca, MSD Oncology

Eva Ciruelos
Consulting or Advisory Role: Roche, Pfizer, AstraZeneca, Novartis, Lilly, MSD Oncology, Daiichi Sankyo/AstraZeneca
Speakers' Bureau: Lilly, Roche, Pfizer, Daiichi Sankyo/AstraZeneca, Novartis
Travel, Accommodations, Expenses: Roche, Pfizer

Komal L. Jhaveri
Consulting or Advisory Role: Novartis, Pfizer, AstraZeneca, Jounce Therapeutics, Synthon, IntelliSphere, Bristol Myers Squibb, Genentech, AbbVie, Lilly, Blueprint Medicines, Seattle Genetics, Daiichi Sankyo, Biotheranostics, Sun Pharma Advanced Research Company, Taiho Oncology, Sanofi, Gilead Sciences
Research Funding: Novartis (Inst), Genentech (Inst), Debiopharm Group (Inst), ADC Therapeutics (Inst), Pfizer (Inst), Novita Pharmaceuticals (Inst), Clovis Oncology (Inst), Lilly (Inst), Zymeworks (Inst), Immunomedics (Inst), Puma Biotechnology (Inst), VelosBio/Merck (Inst), AstraZeneca (Inst)
Travel, Accommodations, Expenses: Taiho Pharmaceutical, Jounce Therapeutics, Pfizer, AstraZeneca, IntelliSphere, Lilly, Gilead Sciences

Rosemary Delaney
Employment: Gilead Sciences
Stock and Other Ownership Interests: Immunomedics (I), Gilead Sciences

Olivia Fu
Employment: Gilead Sciences
Stock and Other Ownership Interests: Gilead Sciences
Travel, Accommodations, Expenses: Gilead Sciences

Lanjia Lin
Employment: Gilead Sciences
Stock and Other Ownership Interests: Gilead Sciences
Travel, Accommodations, Expenses: Gilead Sciences

Wendy Verret
Employment: Roche/Genentech, Gilead Sciences

Sara M. Tolaney
This author is a member of the Journal of Clinical Oncology Editorial Board. Journal policy recused the author from having any role in the peer review of this manuscript.
Consulting or Advisory Role: Novartis, Pfizer, Merck, Lilly, Nektar, NanoString Technologies, AstraZeneca, Puma Biotechnology, Genentech, Eisai, Sanofi, Bristol Myers Squibb, Paxman, Seattle Genetics, Odonate Therapeutics, G1 Therapeutics, OncoPep, Kyowa Hakko Kirin, Samsung Bioepis, CytomX Therapeutics, Daiichi Sankyo, Athenex, Immunomedics/Gilead, Mersana, Certara Inc, 4D Pharma, Ellipses Pharma, OncoSec, Chugai Pharma, BeyondSpring Pharmaceuticals, OncXerna Therapeutics, Infinity Pharmaceuticals, Zymeworks, Zentalis, BluePrint Medicines, Reveal Genomics
Research Funding: Genentech/Roche (Inst), Merck (Inst), Exelixis (Inst), Pfizer (Inst), Lilly (Inst), Novartis (Inst), Bristol Myers Squibb (Inst), Eisai (Inst), AstraZeneca (Inst), NanoString Technologies (Inst), Cyclacel (Inst), Nektar (Inst), Immunomedics (Inst), Odonate Therapeutics (Inst), Sanofi (Inst), Settle Genetics (Inst)
No other potential conflicts of interest were reported.

Author Contributions
Conception and design: Aditya Bardia, Javier Cortes, Peter Schmid, Sara M. Tolaney
Provision of study materials or patients: Aditya Bardia, Frederik Marmé, Javier Cortes, Delphine Loirat, Eva Ciruelos, Florence Dalenc
Collection and assembly of data: Hope S. Rugo, Aditya Bardia, Frederik Marmé, Delphine Loirat, Olivier Trédan, Eva Ciruelos, Patricia Gómez Pardo, Rosemary Delaney, Sara M. Tolaney
Data analysis and interpretation: Hope S. Rugo, Aditya Bardia, Peter Schmid, Delphine Loirat, Eva Ciruelos, Florence Dalenc, Komal L. Jhaveri, Olivia Fu, Lanjia Lin, Wendy Verret, Sara M. Tolaney
Manuscript writing: All authors
Final approval of manuscript: All authors
Accountable for all aspects of the work: All authors

Appendix 1. List of Tropics-02 Study Principal Investigators

Study Investigator	Study Institution
Maysa Abu-Khalaf	Thomas Jefferson University
Foluso Ademuyiwa	Washington University School of Medicine
Clarence Adoo	HonorHealth Research Institute
Philippe Aftimos	Institut Jules Bordet
Samreen Ahmed	University Hospitals of Leicester NHS Trust
Cristina Alencar	Virginia Oncology Associates
Anne Armstrong	The Christie NHS Foundation Trust
Cristina Arqueros	Hospital de la Santa Creu i de Sant Pau
Jean-Pierre Ayoub	Centre Hospitalier De l'Universite De Montreal CHUM
Aditya Bardia^a	Massachusetts General Hospital
J. Thaddeus Beck	Highlands Oncology Group
Giampaolo Bianchini	Ospedale San Raffaele
Sibel Blau	Northwest Medical Specialties, PLLC
Nathalie Bonnin	Hospices Civils de Lyon
Adam Brufsky	UPMC Hillman Cancer Center
Christina Brzezniak	Virginia Cancer Specialists, PC
Giuseppe Cairo	Ospedale Vito Fazzi di Lecce
Lourdes Calvo Martinez	Complejo Hospitalario Universitario A Coruña
Luigi Cavanna	Azienda Unità Sanitaria Locale di Piacenza-Ospedale Guglielmo da Saliceto
Marina Elena Cazzaniga	Azienda Ospedaliera San Gerardo di Monza
Eva Ciruelos	Hospital Universitario 12 de Octubre
Patrick Cobb	Saint Vincent Frontier Cancer Center
Javier Cortes Castan^a	Hospital Ruber Internacional
Ricardo Costa	Moffitt Cancer Center
Florence Dalenc	Institut Claudius Regaud
Maaike de Boer	Maastricht University Medical Center
Neelam Desai	Beth Israel Deaconess Medical Center
Jennifer Diamond	University of Colorado
Erion Dobi	Hôpital Jean Minjoz
Lara Durna	Kaiser Permanente Medical Center
Peter Fasching	Universitätsklinik Erlangen
Gianluigi Ferretti	Istituto Regina Elena
Nelly Firmin	Institut Regional du Cancer de Montpellier
Keerthi Gogineni	Emory University
Patricia Gomez Pardo	Hospital Universitari Vall D'Hebron
Julien Grenier	Institut Sainte Catherine
Erika Hamilton	Tennessee Oncology
Susanna Hegewisch-Becker	Onkologische Schwerpunktpraxis Eppendorf
Stephanie Henry	CHU UCL NAMUR—Sainte Elisabeth
Dawn Hershman	Columbia University Medical Center
Claudine Isaacs	Georgetown University
Jean-Philippe Jacquin	Institut de Cancerologie Lucien Neuwirth
Komal Jhaveri	Memorial Sloan-Kettering Cancer Center
Virginia Kaklamani	University of Texas Health Science Center at San Antonio
Hans-Christian Kolberg	Marienhospital Bottrop
Amy Krie	Virginia Piper Cancer Center (Alliant Health)
Christian Kurbacher	Gynakologisches Zentrum Bonn
Charles Kurkul	Texas Oncology PA
Sylvain Ladoire	Centre Georges François Leclerc
Sabine Linn	Antoni van Leeuwenhoekziekenhuis
Delphine Loirat	Institut Curie
Rafael Lopez	Hospital Clínico Universitario de Santiago de Compostela—CHUS
Kristina Lübbe	DIAKOVERE Krankenhaus gGmbH Henriettenstift—Standort Kirchrode
Hans-Joachim Luck	Gynakologisch-Onkologische Praxis Hannover
Elisabeth Luporsi	Hôpital de Mercy
Ling Ma	Rocky Mountain Cancer Center
Rolf Mahlberg	Klinikum Mutterhaus der Borromaerinnen
Frederik Marme^a	Universitatsmedizin Mannheim
Miguel Martin Jimenez	Hospital General Universitario Gregorio Marañón
Eduardo Martinez	Hospital Provincial de Castellón
Ingrid Mayer	Vanderbilt University
Kelly McCann	University of California Los Angeles (UCLA)
Serafín Morales	Hospital Universitari Arnau De Vilanova (Huav)
Sarah Mougalian	Yale University
Rita Nanda	University of Chicago
Polly Niravath	Houston Methodist Hospital
Yelena Novik	New York University School of Medicine
Shannon O'Connor	Maryland Oncology Hematology
Alicia Okines	The Royal Marsden NHS Foundation Trust
Coral Omene	Rutgers Cancer Institute of New Jersey
Rianne Oosterkamp	Medisch Centrum Haaglanden Antoniushove
Joyce O'Shaughnessy	Texas Oncology
Steven Papish	Summit Medical Group
Ritesh Parajuli	University of California Irvine (UCIMC)
Felicity Paterson	Royal Surrey County Hospital NHS Foundation Trust
Michel Pavic	Centre Hospitalier De I'Universite De Sherbrooke Hôpital Fleurimont
Rebecca Pedersini	Azienda Ospedaliera Spedali Civili di Brescia
Alejandra Perez	Sylvester Comprehensive Cancer Center
Timothy Pluard	St Luke's Cancer Institute
David Potter	Masonic Cancer Center
Paola Pozzi	Ospedale di Desio
Kevin Punie	Universitaire Ziekenhuis Leuven
Fabricio Racca	Hospital Quironsalud Barcelona
Daniel Rayson	Queen Elizabeth II Health Sciences Center
Mattea Reinisch	Kliniken Essen-Mitte
Paul Richards	Blue RidgeCancer Care
Elizabeth Riley	James Graham Brown Cancer Center
David Riseberg	Mercy Medical Center
Regan Rostorfer	University of Florida
Hope Rugo^a	University of California San Francisco
Manuel Ruiz Borrego	Hospital Universitario Virgen del Rocio
Sagar Sardesai	Stefanie Spielman Comprehensive Breast Center
Peter Schmid^a	Barts Health NHS Trust
Andreas Schneeweiss	Nationales Centrum für Tumorerkrankungen Heidelberg
Holger Schultz	HELIOS Klinikum Berlin-Buch
Lee Schwartzberg	West Clinic
Lasika Seneviratne	Los Angeles Hematology Oncology Medical Group
Priyanka Sharma	University of Kansas
Sasha Strain	Texas Oncology PA
Rachel Swart	Arizona Oncology Associates
Karen Tedesco	New York Oncology Hematology—Amsterdam Cancer Center
Hans Tesch	Centrum für Hämatologie und Onkologie Bethanien
Amy Tiersten	Mount Sinai
Sara Tolaney^a	Dana Farber Cancer Institute
Olivier Trédan	Centre Leon Berard
Nisha Unni	University of Texas Southwestern Medical Center
Thierry Velu	Chirec Cancer Institute
Hermann Voss	Stadtisches Klinikum Dessau
Grace Wang	Baptist Health—Miami Cancer Institute
Rudolf Weide	Praxisklinik für Hämatologie und Onkologie Koblenz
Duncan Wheatley	Royal Cornwall Hospital Trust
Kay Yeung	University of California San Diego
Amelia Zelnak	Northside Hospital Atlanta
^aDenotes members of the TROPiCS-02 scientific steering committee.

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Sacituzumab Govitecan in Hormone Receptor–Positive/Human Epidermal Growth Factor Receptor 2–Negative Metastatic Breast Cancer

Abstract and Introduction

Abstract

Introduction

Tables

Tables

Tables

References

Authors and Disclosures

Authors and Disclosures

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Context

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Appendix 1. List of Tropics-02 Study Principal Investigators

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