A study to compare study medication Sacituzumab Govitecan to Standard of Care in Metastatic Breast Cancer which has progressed or returned after at least 2 prior treatments.
- Conditions
- Hormonal Receptor-Positive (HR+) Human Epidermal Growth FactorReceptor 2 (HER2) Negative Metastatic Breast Cancer (MBC)MedDRA version: 20.0Level: LLTClassification code 10027475Term: Metastatic breast cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 20.0Level: PTClassification code 10006198Term: Breast cancer recurrentSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 20.1Level: PTClassification code 10055113Term: Breast cancer metastaticSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2018-004201-33-FR
- Lead Sponsor
- Immunomedics, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 400
1. Female or male subjects aged =18 years at the time of signing the informed consent form (ICF).
2. Documented evidence of hormone receptor-positive HER2-negative (HR+/HER2-) MBC confirmed (local laboratory) with the most recently available or newly obtained tumor biopsy (within last 12 months) from a locally recurrent or metastatic site(s) and defined per ASCO/CAP criteria as: HR positive and HER2-negative.
3. Availability of archival tumor tissue (within 12 months prior to randomization) or newly acquired biopsy from a metastatic site.
4. Refractory to or relapsed after at least 2, and no more than 4, prior systemic chemotherapy regimens for MBC.
5. Subjects should have been previously treated with:
- Taxanes in any setting.
- At least 1 prior anticancer hormonal treatment.
- At least 1 cyclin-dependent kinase inhibitor 4/6 in the metastatic setting.
6. Eligible for one of the chemotherapy options listed in the TPC arm.
7. Documented disease progression after the most recent therapy.
8. At least 1 measurable target lesion according to RECIST 1.1 (bony disease only is not allowed) meeting all of the following criteria:
- Lymph node (LN) lesion that measures at least one dimension as =1.5 cm in the short axis.
- Non-nodal lesion that measures =1.0 cm in the longest diameter.
- The lesion is suitable for repeat measurement using CT/MRI.
- Lesions that have had EBRT or locoregional therapy must show radiographic evidence of disease progression based on RECIST 1.1 to be deemed a target lesion.
9. Brain MRI must be conducted for subjects with a history of brain metastasis. The subject must have had stable CNS disease for at least 4 weeks.
10. Life expectancy of =3 months from randomization based on the PI’s assessment.
11. ECOG performance status of 0 or 1 (as assessed within 10 days prior to the start of study treatment).
12. Adequate renal function.
13. Adequate bone marrow function
Note: Blood transfusion or growth factor support is not allowed within 14 days prior to screening labs.
14. Adequate liver function.
15. Resolution of all systemic anticancer therapy-related or radiation-related toxicities to Grade 1 severity or lower, except for stable sensory neuropathy (=Grade 2) and alopecia. Subjects with Grade 2 neuropathy are eligible but may not receive vinorelbine as TPC.
16. Females must not be lactating or pregnant at Screening or Baseline (as documented by a negative ß-hCG or hCG) test. A separate baseline assessment is required if a negative screening serum pregnancy test was obtained more than 72 hours before the first dose of study drug.
- All females will be considered to be of childbearing potential unless they are postmenopausal or have been sterilized surgically.
17. Females of childbearing potential must not have had unprotected sexual intercourse within 30 days before study entry and must agree to use a highly effective method of contraception throughout the entire study period and for 120 days after study drug discontinuation. For sites outside of the EU, it is permissible that if a highly effective method of contraception is not appropriate or acceptable to the subject, then the subject must agree to use a medically acceptable method of contraception.Females who are using hormonal contraceptives must have been on a stable dose of the same hormonal contraceptive product for at least 28 days before dosing and must continue to use the same contraceptive during the study and for 120 days after stu
1. Previous treatment with Topoisomerase 1 Inhibitors as a free form or as other formulations.
2. Current enrollment in another clinical study or used any investigational drug or device within the past 28 days preceding informed consent.
3. Treatment with chemotherapy or biological therapy within 3 weeks prior to the first dose of study treatment, or radiation or small molecule targeted therapy within 2 weeks prior to the first dose of study treatment.
4. Existing anticancer treatment-related AEs of Grade =2 (except for alopecia and Grade 2 sensory neuropathy) according to NCI-CTCAE v5.0.
5. Any other malignancy that required treatment or has shown evidence of recurrence (except for non-melanoma skin cancer, or histologically confirmed complete excision of carcinoma in situ) during the 5 years prior to enrollment in this study.
6. History of significant cardiovascular disease, defined as:
- Congestive heart failure greater than New York Heart Association (NYHA) Class II according to the NYHA Functional Classification.
- Unstable angina or myocardial infarction within 6 months before enrollment.
- Serious cardiac arrhythmia.
7. Clinically significant ECG abnormality, including:
- Marked Baseline prolonged QT/QTc interval (ie, a repeated demonstration of a QTc interval >500 ms) demonstrated on ECG at Screening.
- History of risk factors for torsade de pointes (eg, heart failure, hypokalemia, family history of long QT Syndrome).
8. Has known active CNS metastases and/or carcinomatous meningitis. Subjects with previously treated brain metastases may participate provided they have stable CNS disease for at least 4 weeks prior to the first dose of study drug and all neurologic symptoms have returned to baseline, have no evidence of new or enlarging brain metastases, and are taking =10mg/day of prednisone or its equivalent. All subjects with carcinomatous meningitis are excluded regardless of clinical stability.
9. Active hepatitis B virus (positive hepatitis B surface antigen) or active hepatitis C virus (measurable viral RNA load with polymerase chain reaction) infection.
10. Scheduled surgery during the study, other than minor surgery which would not delay study treatment.
11. Has an active infection requiring IV systemic therapy.
12. Subjects with active chronic inflammatory bowel disease (ulcerative colitis, Crohn’s disease) and subjects with a history of bowel obstruction.
13. Subjects who have received a live vaccine within 30 days of randomization.
14. Known hypersensitivity or intolerance to either of the study drugs or any of the excipients.
15. Any medical or other condition which, in the opinion of the Investigator, causes the subject to be medically unfit to receive Sacituzumab Govitecan, or unsuitable for any other reason.
16. Is receiving any medication prohibited in combination with the study treatment(s) as described in the respective product labels, unless medication was stopped within 7 days prior to randomization.
17. Locally advanced MBC (stage IIIc) in subjects who are candidates for curative intent therapy at the time of study enrollment.
18. Has Gilbert’s disease.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method