Trial record 1 of 1 for:
ascent-05
Study of Sacituzumab Govitecan-hziy and Pembrolizumab Versus Treatment of Physician's Choice in Patients With Triple Negative Breast Cancer Who Have Residual Invasive Disease After Surgery and Neoadjuvant Therapy (ASCENT-05)
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| ClinicalTrials.gov Identifier: NCT05633654 |
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Recruitment Status :
Recruiting
First Posted : December 1, 2022
Last Update Posted : November 2, 2023
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Sponsor:
Gilead Sciences
Collaborator:
Alliance Foundation Trials, LLC.
Information provided by (Responsible Party):
Gilead Sciences
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Brief Summary:
The goal of this study is to find out if the experimental product, sacituzumab govitecan-hziy (SG) in combination with pembrolizumab given after surgery, is effective and safe compared to the treatment of physician's choice (TPC) which includes either pembrolizumab or pembrolizumab plus capecitabine in participants with triple negative breast cancer that still remains after surgery and pre-surgical treatment.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Triple Negative Breast Cancer | Drug: Sacituzumab govitecan-hziy (SG) Drug: Pembrolizumab Drug: Capecitabine | Phase 3 |
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 1514 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | A Randomized, Open-label, Phase 3 Study of Adjuvant Sacituzumab Govitecan and Pembrolizumab Versus Treatment of Physician's Choice in Patients With Triple Negative Breast Cancer Who Have Residual Invasive Disease After Surgery and Neoadjuvant Therapy |
| Actual Study Start Date : | December 12, 2022 |
| Estimated Primary Completion Date : | June 2027 |
| Estimated Study Completion Date : | August 2031 |
Resource links provided by the National Library of Medicine
MedlinePlus Genetics related topics:
Breast cancer
MedlinePlus related topics:
Breast Cancer
| Arm | Intervention/treatment |
|---|---|
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Experimental: Sacituzumab govitecan-hziy (SG) + Pembrolizumab
Participants will receive SG 10 mg/kg intravenously on Days 1 and 8 of 21-day cycles and pembrolizumab 200 mg intravenously on Day 1 of 21-day cycles for 8 cycles. Treatment will be administered until a maximum of 8 cycles, local or distant disease recurrence, unacceptable toxicity, physician decision, consent withdrawal, or death. |
Drug: Sacituzumab govitecan-hziy (SG)
Administered intravenously
Other Names:
Drug: Pembrolizumab Administered intravenously
Other Name: Keytruda® |
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Active Comparator: Treatment of Physician's Choice (TPC): Pembrolizumab or Pembrolizumab + Capecitabine
Participants will receive one of the following TPC regimens determined prior to randomization:
Treatment will be administered until a maximum of 8 cycles, local or distant disease recurrence, unacceptable toxicity, physician decision, consent withdrawal, or death. |
Drug: Pembrolizumab
Administered intravenously
Other Name: Keytruda® Drug: Capecitabine Tablets administered orally
Other Name: Xeloda |
Primary Outcome Measures :
- Invasive Disease-free Survival (iDFS) [ Time Frame: Up to 60 months ]iDFS is defined as the time from the date of randomization to death from any cause or one of the following events (whichever occurs first): invasive local, regional, or distant recurrence, invasive contralateral breast cancer.
Secondary Outcome Measures :
- Overall Survival (OS) [ Time Frame: Up to 96 months ]OS is defined as the time from the date of randomization until death due to any cause.
- Distant Disease-free Survival (dDFS) [ Time Frame: Up to 60 months ]dDFS is defined as the time from the date of randomization to death from any cause or one of the following events (whichever occurs first): distant recurrence, or second primary invasive cancer.
- Recurrence-free Survival (RFS) [ Time Frame: Up to 60 months ]RFS is defined as the time from the date of randomization to death from any cause or one of the following events (whichever occurs first): invasive local, regional, or distant recurrence.
- Percentage of Participants Experiencing Treatment-emergent Adverse Events (TEAEs) [ Time Frame: First dose date up to 38 months plus 30 days ]
- Percentage of Participants Experiencing Laboratory Abnormalities [ Time Frame: First dose date up to 38 months plus 30 days ]
- Time to Worsening (TTW) of Quality of Life (QoL) Based on Functional Assessment of Cancer Therapy for Breast Cancer (FACT-B) Trial Outcome Index (TOI) Scores [ Time Frame: Up to 60 months ]TTW of FACT-B TOI scores will be analyzed for each index, the TTW of FACT-B scores will be measured from the randomization date and to the time the participants first experienced a first score of worsening.
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Key Inclusion Criteria:
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Age > 18 years, with residual invasive triple negative breast cancer (TNBC) in the breast or lymph nodes after neoadjuvant therapy and surgery:
- TNBC criteria for the study is defined as estrogen receptor (ER) and progesterone receptor (PR) < 10%, human epidermal growth factor receptor 2 (HER2)-negative per American Society of Clinical Oncology and College of American Pathologists (ASCO/CAP) guidelines (immunohistochemistry (IHC) and/or in situ hybridization (ISH)).
- Adequate excision and surgical removal of all clinically evident of disease in the breast and/or lymph nodes and have adequately recovered from surgery.
- Submission of both pre-neoadjuvant treatment diagnostic biopsy and resected residual invasive disease tissue.
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
- Individuals must have received appropriate radiotherapy and have recovered prior to starting study treatment.
- Adequate organ function.
Key Exclusion Criteria:
- Stage IV (metastatic) breast cancer as well as history of any prior (ipsi- or contralateral) invasive breast cancer.
- Prior treatment with another stimulatory or coinhibitory T-cell receptor agent (eg, cytotoxic T-lymphocyte-associated antigen 4 (CTLA-4), OX-40, cluster of differentiation 137 (CD137), prior treatment with any HER2-directed agent.
- Evidence of recurrent disease following preoperative therapy and surgery.
- Prior treatment with topoisomerase 1 inhibitors or antibody-drug conjugates (ADCs) containing a topoisomerase inhibitor.
- Individuals with known germline breast cancer gene (BRCA) mutations.
- Myocardial infarction or unstable angina pectoris within 6 months of enrollment or history of serious ventricular arrhythmia (ie, ventricular tachycardia or ventricular fibrillation), high-grade atrioventricular block, or other cardiac arrhythmias or Left ventricular ejection fraction (LVEF) of < 50%
- Active serious infections requiring anti-microbial therapy.
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05633654
Contacts
| Contact: Gilead Clinical Study Information Center | 1-833-445-3230 (GILEAD-0) | GileadClinicalTrials@gilead.com |
Locations
Show 47 study locations
Sponsors and Collaborators
Gilead Sciences
Alliance Foundation Trials, LLC.
Investigators
| Study Director: | Gilead Study Director | Gilead Sciences |
Additional Information:
| Responsible Party: | Gilead Sciences |
| ClinicalTrials.gov Identifier: | NCT05633654 |
| Other Study ID Numbers: |
GS-US-595-6184 |
| First Posted: | December 1, 2022 Key Record Dates |
| Last Update Posted: | November 2, 2023 |
| Last Verified: | November 2023 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
Keywords provided by Gilead Sciences:
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OptimICE-RD AFT-65 |
Additional relevant MeSH terms:
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Breast Neoplasms Triple Negative Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases Pembrolizumab Capecitabine Sacituzumab govitecan |
Antineoplastic Agents, Immunological Antineoplastic Agents Immune Checkpoint Inhibitors Molecular Mechanisms of Pharmacological Action Antimetabolites, Antineoplastic Antimetabolites Immunoconjugates Immunologic Factors Physiological Effects of Drugs |