Study of Sacituzumab Govitecan and Pembrolizumab Compared to Physician's Choice Treatment and Pembrolizumab in Adults with Previously Untreated, Locally Advanced, Unresectable or Metastatic Triple-Negative Breast Cancer

Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, Czechia, France, Germany, Hong Kong, Hungary, Israel, Italy, Japan, Malaysia, Mexico, Netherlands, Poland, Puerto Rico, Singapore, South Africa, South Korea, Spain, Switzerland, Taiwan, Turkey (T�rkiye), United Kingdom, United States (ICTRP)

ID di studio ICTRP
NCT05382286 (ICTRP)

Titolo ufficiale (approvato dal comitato etico)
A Randomized, Open-label, Phase 3 Study of Sacituzumab Govitecan and Pembrolizumab Versus Treatment of Physician’s Choice and Pembrolizumab in Patients with Previously Untreated, Locally Advanced Inoperable or Metastatic Triple-Negative Breast Cancer Whose Tumors Express PD-L1 (BASEC)

Titolo accademico
A Randomized, Open-label, Phase 3 Study of Sacituzumab Govitecan and Pembrolizumab Versus Treatment of Physician's Choice and Pembrolizumab in Patients With Previously Untreated, Locally Advanced Inoperable or Metastatic Triple-Negative Breast Cancer, Whose Tumors Express PD-L1 (ICTRP)

Titolo pubblico
Study of Sacituzumab Govitecan-hziy and Pembrolizumab Versus Treatment of Physician's Choice and Pembrolizumab in Patients With Previously Untreated, Locally Advanced Inoperable or Metastatic Triple-Negative Breast Cancer (ICTRP)

Malattie studiate
Triple Negative Breast CancerPD-L1 Positive (ICTRP)

Intervento studiato
Drug: Sacituzumab Govitecan-hziyDrug: PembrolizumabDrug: PaclitaxelDrug: nab-PaclitaxelDrug: GemcitabineDrug: Carboplatin (ICTRP)

Tipo di studio
Interventional (ICTRP)

Disegno dello studio
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label). (ICTRP)

Criteri di inclusione/esclusione
Key Inclusion Criteria:

- Individuals with locally advanced, inoperable, or metastatic triple-negative breast
cancer (TNBC) who have not received previous systemic therapy for advanced disease
and whose tumors are programmed cell death ligand 1 (PD-L1) positive at screening.

- Individuals must have completed treatment for Stage I to III breast cancer, if
indicated, and = 6 months must have elapsed between completion of treatment
with curative intent and first documented local or distant disease recurrence.

- Individuals presenting with de novo metastatic TNBC are eligible for this
study.

- TNBC status and tumor PD-L1 combined positive score (CPS) will be confirmed
centrally on a recent or archival tumor specimen.

- Individuals must have measurable disease by computed tomography (CT) or
magnetic resonance imaging (MRI) as per Response Evaluation Criteria in Solid
Tumors (RECIST) Version 1.1 criteria as evaluated locally.

- Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.

- Demonstrates adequate organ function

- Male and female individuals of childbearing potential who engage in heterosexual
intercourse must agree to use protocol-specified method(s) of contraception.

- Individuals with HIV must be on antiretroviral therapy (ART) and have a
well-controlled HIV infection/disease.

Key Exclusion Criteria:

- Positive serum pregnancy test or women who are lactating.

- Received prior therapy with an agent directed to another stimulatory or coinhibitory
T-cell receptor.

- Individuals may not have received systemic anticancer treatment (with the exception
of endocrine therapy) within the previous 6 months or radiation therapy within 2
weeks prior to enrollment.

- Individuals may not be participating in a study with an investigational agent or
investigational device within 4 weeks prior to randomization. Individuals
participating in observational studies are eligible.

- Have previously received topoisomerase 1 inhibitors or antibody drug conjugates
containing a topoisomerase inhibitor.

- Have an active second malignancy.

- Have active serious infection requiring antibiotics.

- Individuals positive for HIV-1 or 2 with a history of Kaposi sarcoma and/or
Multicentric Castleman Disease.

- Have active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection.

- Has an active autoimmune disease that has required systemic treatment in the past 2
years.

Note: Other protocol defined Inclusion/Exclusion criteria may apply. (ICTRP)

non disponibile

Endpoint primari e secondari
Progression-free Survival (PFS) as Assessed by Blinded Independent Central Review (BICR) per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 (ICTRP)

Overall Survival (OS);Objective Response Rate (ORR) as Assessed by BICR per RECIST Version 1.1;Duration of Response (DOR) as Assessed by BICR per RECIST Version 1.1;Time to Response (TTR) as Assessed by BICR per RECIST Version 1.1;Percentage of Participants Experiencing Treatment-emergent Adverse Events (TEAEs);Percentage of Participants Experiencing Clinical Laboratory Abnormalities;Time to Deterioration (TTD) in Global Health Status/Quality of Life (QoL) Scale as Measured by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire, Core Questionnaire, Version 3.0 (EORTC QLQ-C30);TTD of Pain Score as Measured by EORTC QLQ-C30;TTD of Fatigue Score as Measured by EORTC QLQ-C30;TTD of Physical Functioning Domain Score as Measured by EORTC QLQ-C30;TTD of Role Functioning Score as Measured by EORTC QLQ-C30 (ICTRP)

Data di registrazione
non disponibile

Inclusione del primo partecipante
non disponibile

Sponsor secondari
Merck Sharp & Dohme LLC (ICTRP)

Contatti aggiuntivi
Gilead Study Director, Gilead Sciences (ICTRP)

ID secondari
2021-005742-14, KEYNOTE-D19, jRCT2041220123, MK-3475-D19, 2023-504194-21, GS-US-592-6173 (ICTRP)

Risultati-Dati individuali dei partecipanti
non disponibile

Ulteriori informazioni sullo studio
https://clinicaltrials.gov/study/NCT05382286 (ICTRP)