Relapsed/Refractory Triple-Negative Breast Cancer MedDRA version: 20.0 Level: PT Classification code 10075566 Term: Triple negative breast cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 20.0 Level: LLT Classification code 10027475 Term: Metastatic breast cancer
Conditions
Interventions
Product Name: Sacituzumab govitecan
Product Code: IMMU-132, hRS7-SN38
Pharmaceutical Form: Powder for solution for infusion
INN or Proposed INN: sacituz
Sponsors
Immunomedics, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Female or male patients, =18 years of age, able to understand and give written informed consent. 2. Histologically or cytologically confirmed TNBC per ASCO/CAP criteria, based on the most recent analyzed biopsy or other pathology specimen. Triple negative is defined as 9 g/dL, ANC > 1,500 per mm3, platelets > 100,000 per mm3). Blood transfusion or growth factor support is not allowed within 14 days prior to screening labs. 11. Adequate renal and hepati
Exclusion criteria
Exclusion criteria: 1. Women who are pregnant or lactating. 2. Women of childbearing potential or fertile men unwilling to use highly effective * contraception during study and up to three months after treatment discontinuation in women of child-bearing potential and six months in males post last study drug. 3. Patients with Gilbert’s disease. 4. Patients with non-melanoma skin cancer or carcinoma in situ of the cervix are eligible, while patients with other prior malignancies must have had at least a 3-year disease-free interval. 5. Patients known to be HIV positive. 6. Patients with hepatitis B positive, or hepatitis C positive infection**. 7. Known history of unstable angina, MI, or CHF present within 6 months of randomization or clinically significant cardiac arrhythmia (other than stable atrial fibrillation) requiring anti-arrhythmia therapy. 8. Known history of clinically significant active COPD, or other moderate-to-severe chronic respiratory illness present within 6 months of randomization. 9. Prior history of clinically significant bleeding, intestinal obstruction, or GI perforation within 6 months of randomization. 10. Infection requiring antibiotic use within one week of randomization. 11. Patients with active chronic inflammatory bowel disease (ulcerative colitis, Crohn disease) and patients with a history of bowel obstruction 12. Patients who have received a live vaccine within 30 days of randomization 13. Patients who previously received irinotecan. 14. Rapid deterioration during screening prior to randomization, e.g. significant change in performance status, = 20% decrease in serum albumin levels, unstable pain symptoms requiring modifications in analgesic management. 15. Other concurrent medical or psychiatric conditions that, in the Investigator’s opinion, may be likely to confound study interpretation or prevent completion of study procedures and follow-up examinations. *Highly effective is defined as i.e. Combined (estrogen and progestogen containing) hormonal contraception: oral, intravaginal, transdermal, progestin -only hormonal contraception associated with inhibition of ovulation: oral, injectable, implantable, intrauterine device (IUD), intrauterine hormone-releasing system (IUS), bilateral tubal occlusion, vasectomized partner, sexual abstinence). Abstinence refers to ‘True abstinence’ which means it is in line with the preferred and usual lifestyle of the patient. Periodic abstinence (e.g., calendar, ovulation, symptotherma, post-ovulation methods), declaration of abstinence for the duration of exposure to study treatment, and withdrawal are not acceptable methods of contraception. ** In patients with a history of HBV, hepatitis B core antibody (HBcAb) testing is required and if positive, then HB DNA testing will be performed and if positive the patient will be excluded.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study is to compare the efficacy of sacituzumab govitecan to the treatment of physician’s choice (TPC) as measured by independently reviewed (IRC) progression-free survival (PFS) in patients with locally advanced or metastatic TNBC previously treated with at least two systemic chemotherapy regimens for unresectable, locally advanced or metastatic disease, and without brain metastasis at baseline.; Secondary Objective: The secondary objectives of the study are to compare between the two treatment groups for: - PFS for the ITT population - Overall Survival (OS) in both the ITT population and in the subgroup with brain metastasis. - Independently-determined Objective Response Rate (ORR), duration of response and time to onset of response per RECIST 1.1 criteria - Quality of life - Safety (adverse events, safety laboratories, incidence of dose delays and dose reductions, treatment discontinuations due to adverse events) ; Primary end point(s): Progression-free survival (PFS) as determined by an independent centralized blinded assessment. ;Timepoint(s) of evaluation of this end point: Monitored throughout the study | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Overall survival (OS) - Progression Free Survival (PFS) in the ITT population. - Objective response rate (ORR), duration of response, and time to onset of response - Quality of life - Safety, including: adverse events; safety laboratories and evaluations; incidence of dose delays and dose reductions; and treatment discontinuations due to adverse events ;Timepoint(s) of evaluation of this end point: Monitored throughout the study | — |
Countries
Belgium, Canada, France, Germany, Ireland, Italy, Spain, United Kingdom, United States
Contacts
Public ContactClinical Trial Information Desk
Immunomedics, Inc.
Outcome results
None listed