Sacituzumab Govitecan In TNBC (NeoSTAR)
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ClinicalTrials.gov Identifier: NCT04230109 |
Recruitment Status :
Recruiting
First Posted : January 18, 2020
Last Update Posted : March 19, 2024
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Tracking Information | |||||||||||||||
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First Submitted Date ICMJE | January 13, 2020 | ||||||||||||||
First Posted Date ICMJE | January 18, 2020 | ||||||||||||||
Last Update Posted Date | March 19, 2024 | ||||||||||||||
Actual Study Start Date ICMJE | July 14, 2020 | ||||||||||||||
Estimated Primary Completion Date | October 2025 (Final data collection date for primary outcome measure) | ||||||||||||||
Current Primary Outcome Measures ICMJE |
Pathological complete response(pCR) rate with sacituzumab govitecan [ Time Frame: 12 Weeks ] pCR is defined as no residual invasive carcinoma in the breast and in the lymph node. The two-sided 95% CIs for pCR rate will be calculated.
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Original Primary Outcome Measures ICMJE | Same as current | ||||||||||||||
Change History | |||||||||||||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | ||||||||||||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||||||||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||||||||||
Descriptive Information | |||||||||||||||
Brief Title ICMJE | Sacituzumab Govitecan In TNBC | ||||||||||||||
Official Title ICMJE | A Phase 2 Study of Response-guided Neoadjuvant Sacituzumab Govitecan (IMMU-132) in Patients With Localized Triple-Negative Breast Cancer (NeoSTAR) | ||||||||||||||
Brief Summary | This research study is studying to evaluate sacituzumab govitecan for individuals with localized triple negative breast cancer (TNBC) The names of the study drugs involved in this study is:
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Detailed Description | This research study is a Phase II clinical trial. Phase II clinical trials test the safety and effectiveness of an investigational drug to learn whether the drug works in treating a specific disease. "Investigational" means that the drug is being studied. This research study involves an experimental study treatment. The names of the study drugs involved in this study is:
The study is a umbrella study multi-arm phase II study of neoadjuvant SG-based therapy in patients with localized BC. The first cohort involves SG monotherapy. After the monotherapy cohort completes enrollment, the combination therapy cohort (SG with pembrolizumab) for patients with localized BC will open. Future planned arms include SG with/without pembrolizumab for patients with Hormone Receptor positive (HR+) breast cancer and inflammatory breast cancer (IBC). The research study procedures include screening for eligibility and study treatment including evaluations and follow up visits.
The U.S. Food and Drug Administration (FDA) has not approved Sacituzumab govitecan as a treatment for patients with metastatic TNBC. Sacituzumab govitecan (SG) is an antibody-drug conjugate which means it's made up of an antibody attached to an anticancer drug. An antibody is a protein normally made the immune system. Sacituzumab govitecan is believed to work by binding the antibody portion of the drug in the tumor(s) while the anticancer drug portion works to prevent cancer cells from growing/spreading. After the SG monotherapy cohort completes enrollment, the combination therapy cohort (SG with immunotherapy) will open. |
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Study Type ICMJE | Interventional | ||||||||||||||
Study Phase ICMJE | Phase 2 | ||||||||||||||
Study Design ICMJE | Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE |
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Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | ||||||||||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||||||||||
Recruitment Status ICMJE | Recruiting | ||||||||||||||
Estimated Enrollment ICMJE |
260 | ||||||||||||||
Original Estimated Enrollment ICMJE |
50 | ||||||||||||||
Estimated Study Completion Date ICMJE | October 2026 | ||||||||||||||
Estimated Primary Completion Date | October 2025 (Final data collection date for primary outcome measure) | ||||||||||||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||||||||||||
Accepts Healthy Volunteers ICMJE | No | ||||||||||||||
Contacts ICMJE |
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Listed Location Countries ICMJE | United States | ||||||||||||||
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Administrative Information | |||||||||||||||
NCT Number ICMJE | NCT04230109 | ||||||||||||||
Other Study ID Numbers ICMJE | 19-578 | ||||||||||||||
Has Data Monitoring Committee | Yes | ||||||||||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Current Responsible Party | Laura M. Spring, MD, Massachusetts General Hospital | ||||||||||||||
Original Responsible Party | Aditya Bardia, Massachusetts General Hospital, Sponsor Investigator | ||||||||||||||
Current Study Sponsor ICMJE | Massachusetts General Hospital | ||||||||||||||
Original Study Sponsor ICMJE | Aditya Bardia | ||||||||||||||
Collaborators ICMJE | Gilead Sciences | ||||||||||||||
Investigators ICMJE |
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PRS Account | Massachusetts General Hospital | ||||||||||||||
Verification Date | March 2024 | ||||||||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |