A Randomized, Open-label, Phase 3 Study of Sacituzumab Govitecan versus Treatment of Physician s Choice in Patients With Hormone Receptor-Positive (HR+)/Human Epidermal Growth Factor Receptor 2 Negative (HER-) (HER2 IHC0 or HER2-low [IHC 1+, IHC 2+/ISH-]) Inoperable, Locally Advanced, or Metastatic Breast Cancer and Have Received Endocrine Therapy.
Primary Objective:
To compare the effect of SG relative to the TPC on PFS.
Secondary Objectives:
To compare the effect of SG relative to TPC on the following:
- OS
- ORR
- Change from baseline in physical functioning domain and time to definitive deterioration
(TTDD) in Global Health Status/quality of life (QoL) as measured by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Version 3.0 (EORTC QLQ-C30).
Sacitzumab govitecan/IMMU-132
Nab-paclitaxel
CAPECITABINE
- Rutgers Cancer Institute of New Jersey
- RWJBarnabas Health
- Cooperman Barnabas, Livingston
- Monmouth Medical Center
- Monmouth Medical Center Southern Campus
- Monmouth Medical Center Vantage Point Center
- Robert Wood Johnson University Hospital, Somerset
- Trinitas Hospital and Comprehensive Cancer Center
- Rutgers Cancer Institute of New Jersey-University Hospital
Key Inclusion Criteria
- Able to understand and give written informed consent.
- Must have adequate tumor tissue sample preferably from locally recurrent or metastatic
site.
- Documented evidence of HR+ metastatic breast cancer (mBC) confirmed with the most
recently available tumor biopsy preferably from a locally recurrent or metastatic
site.
- Documented evidence of HER2- status.
- Documented PD by computed tomography (CT) or magnetic resonance imaging during or
after the most recent therapy per RECIST v1.1 criteria.
- Candidate for the first chemotherapy in the locally advanced or metastatic setting.
- Eligible for capecitabine, nab-paclitaxel, or paclitaxel.
- Individuals must have at least one of the following:
- Disease progression on at least 2 or more previous lines of endocrine therapy
(ET) with or without a targeted therapy in the metastatic setting.
- Disease recurrence while on the first 24 months of starting adjuvant ET will
be considered a line of therapy; these individuals will only require 1 line
of ET in the metastatic setting.
- Disease progression within 6 months of starting first-line ET with or without a
cyclin-dependent kinase (CDK) 4/6 inhibitor (if ineligible or if unable to access
a CDK 4/6 inhibitor) in the metastatic setting.
- Disease recurrence while on the first 24 months of starting adjuvant ET with CDK
4/6 inhibitor and if the individual is no longer a candidate for additional ET in
the metastatic setting.
- Individuals may have received prior targeted therapies, including but not limited to
PARP inhibitors (for those with germline BRCA1 or BRCA2 mutations),
phosphatidylinositol 3-kinase (PI3K) inhibitors (for those with PIK3CA mutations), or
mammalian target of rapamycin (mTOR) inhibitors. However, individuals can no longer be
candidates for additional endocrine treatment with or without targeted therapies.
- Individuals with HIV must be on antiretroviral therapy (ART) and have a
well-controlled HIV infection/disease.
- Demonstrates adequate organ function.
- Male individuals and female individuals of childbearing potential who engage in
heterosexual intercourse must agree to use protocol-specified method(s) of
contraception.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
Key Exclusion Criteria
- Progressive disease within 6 months of completing (neo)adjuvant chemotherapy.
- Locally advanced metastatic breast cancer (mBC) (Stage IIIc) in individuals who are
candidates for curative intent therapy at the time of study enrollment.
- Current enrollment in another clinical study and use of any investigational device or
drug (drugs not marketed for any indication) either within 5 half-lives or 28 days
prior to randomization, whichever is longer.
- Use of investigational drugs in the category of Selective Estrogen Receptor
Degraders are acceptable if last dose was longer than 14 days prior to
randomization.
- Received any prior treatment (including antibody-drug conjugate (ADC)) containing a
chemotherapeutic agent targeting topoisomerase I.
- Received any prior treatment with a trophoblast cell-surface antigen 2
(Trop-2)-directed ADC.
- Have an active second malignancy.
- Have an active serious infection requiring antibiotics.
- Have active hepatitis B virus (HBV) or hepatitis C virus (HCV).
- Individuals positive for human immunodeficiency virus type 1/2 (HIV-1 or -2) with a
history of Kaposi sarcoma and/or Multicentric Castleman Disease.
- Have a positive serum pregnancy test or are breastfeeding for individuals who are
assigned female at birth.
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Please note that we have obtained the inclusion and exclusion criteria information from the National Institutes of Health’s clinical trials web site ClinicalTrials.gov. The listed criteria may not necessarily reflect recent amendments to the protocol and the current criteria.
For further information about clinical trials, please contact us at 732-235-7356.