Study of Sacituzumab Govitecan Compared to Physician's Choice Treatment in Adults with Previously Untreated Metastatic Locally Advanced, Inoperable or Metastatic Triple-Negative Breast Cancer (ASCENT-03).
Zusammenfassung der Studie
This study investigates an experimental drug called Sacituzumab Govitecan in patients with previously untreated, advanced triple-negative breast cancer (TNBC). Advanced TNBC is defined as TNBC that cannot be surgically removed or has spread from the breast to other parts of the body. Sacituzumab govitecan (Trodelvy®) is currently approved by Swissmedic and other regulatory authorities for previously treated advanced TNBC. The aim of this study is to find out whether Sacituzumab Govitecan can improve the survival of patients with advanced TNBC whose tumor is not growing or spreading compared to chemotherapy (a commonly used treatment for previously untreated advanced TNBC). Eligible participants will be randomly assigned (1:1) to either the experimental treatment with Sacituzumab Govitecan OR one of the following three standard chemotherapy treatments selected by the investigator (control group): o Paclitaxel o nab-Paclitaxel o Gemcitabine with Carboplatin How long patients participate in the study overall depends on how the cancer responds to the study treatment. Active participation in the study, including treatment with the investigational drug, may continue as long as the treatment is tolerated safely and the cancer does not worsen or the study is not stopped. Participation in this study may last from one day to 4 years or longer, as long as the treatment is tolerated safely. Study participants must visit the clinic at least 2-3 times per cycle (a cycle consists of 21 or 28 days), depending on which treatment was assigned. During the follow-up period, the clinic may need to be visited every 12 weeks or more frequently.
(BASEC)
Untersuchte Intervention
Eligible participants will be randomly assigned (1:1) to either the experimental treatment with Sacituzumab Govitecan (Group 1) OR the control group (Group 2)
• Group 1 receives Sacituzumab Govitecan 10 mg/kg intravenously (IV) on Days 1 and 8 of 21-day cycles.
• Group 2 receives a treatment selected by the investigator from one of the following 3 chemotherapeutics:
o Paclitaxel: Paclitaxel 90 mg/m² intravenously (IV) on Days 1, 8, and 15 of 28-day cycles
o Nab-Paclitaxel: Nab-Paclitaxel 100 mg/m² intravenously (IV) on Days 1, 8, and 15 of 28-day cycles
o Gemcitabine with Carboplatin: Gemcitabine 1000 mg/m² with Carboplatin area under the curve (AUC)2 intravenously (IV) on Days 1 and 8 of 21-day cycles
(BASEC)
Untersuchte Krankheit(en)
Previously Untreated Metastatic Locally Advanced, Inoperable or Metastatic Triple-Negative Breast Cancer
(BASEC)
Eligible are adults aged ≥ 18 years with locally advanced, inoperable or metastatic triple-negative breast cancer who have not received prior systemic therapy for advanced disease and whose tumors are PD-L1-negative at the time of assessment. Alternatively, patients whose tumors are PD-L1-positive at the time of assessment may be eligible if they have received an anti-PD-(L)1 inhibitor (i.e., a checkpoint inhibitor) in the adjuvant or neoadjuvant setting. Patients must have completed treatment for breast cancer at stage I-III, if indicated, and at least 6 months must have elapsed between the completion of curative intent treatment and the first documented local or distant recurrence of the disease. Patients with de novo metastatic TNBC are eligible for this study; tumors will be centrally assessed for TNBC and PD-L1 status. (BASEC)
Ausschlusskriterien
Positive serum pregnancy test or women who are breastfeeding, known or severe hypersensitivity or allergy to Sacituzumab Govitecan and/or the chemotherapy regimen of choice in the TPC arm, requirement for ongoing therapy with or prior use of prohibited medications. Patients must not have received systemic cancer treatment within the last 6 months or radiation therapy within the 2 weeks prior to study enrollment. Patients must have recovered from any side effects attributable to a previously administered drug at the time of study enrollment. Patients must not have participated in a study with an investigational drug or device within 4 weeks prior to randomization. Patients who have previously received Topoisomerase-1 inhibitors or antibody-drug conjugates containing a Topoisomerase inhibitor are excluded. (BASEC)
Studienstandort
St Gallen
(BASEC)
Sponsor
Gilead Sciences Switzerland
(BASEC)
Kontakt für weitere Auskünfte zur Studie
Kontaktperson Schweiz
Prof. Dr. med. Jens Huober
+41 71 494 18 80
jens.huober@clutterkssg.chKantonsspital Sankt Gallen
(BASEC)
Wissenschaftliche Auskünfte
Gilead Sciences,
1-833-445-3230 (GILEAD-0)
jens.huober@clutterkssg.ch(ICTRP)
Name der bewilligenden Ethikkommission (bei multizentrischen Studien nur die Leitkommission)
Ethikkommission Ostschweiz EKOS
(BASEC)
Datum der Bewilligung durch die Ethikkommission
21.07.2022
(BASEC)
ICTRP Studien-ID
NCT05382299 (ICTRP)
Offizieller Titel (Genehmigt von der Ethikkommission)
A Randomized, Open-label, Phase 3 Study of Sacituzumab Govitecan Versus Treatment of Physician’s Choice in Patients With Previously Untreated, Locally Advanced, Inoperable or Metastatic Triple-Negative Breast Cancer Whose Tumors Do Not Express PD-L1 or in Patients Previously Treated With Anti-PD-(L)1 Agents in the Early Setting Whose Tumors Do Express PD-L1 (BASEC)
Wissenschaftlicher Titel
A Randomized, Open-label, Phase 3 Study of Sacituzumab Govitecan Versus Treatment of Physician's Choice in Patients With Previously Untreated, Locally Advanced, Inoperable or Metastatic Triple-Negative Breast Cancer Whose Tumors Do Not Express PD-L1 or in Patients Previously Treated With Anti-PD-(L)1 Agents in the Early Setting Whose Tumors Do Express PD-L1 (ICTRP)
Öffentlicher Titel
Study of Sacituzumab Govitecan-hziy Versus Treatment of Physician's Choice in Patients With Previously Untreated Locally Advanced Inoperable or Metastatic Triple-Negative Breast Cancer (ICTRP)
Untersuchte Krankheit(en)
Triple Negative Breast CancerPD-L1 Negative (ICTRP)
Untersuchte Intervention
Drug: Sacituzumab Govitecan-hziyDrug: PaclitaxelDrug: nab-PaclitaxelDrug: GemcitabineDrug: Carboplatin (ICTRP)
Studientyp
Interventional (ICTRP)
Studiendesign
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label). (ICTRP)
Ein-/Ausschlusskriterien
Key Inclusion Criteria:
- Individuals, regardless of race and ethnic group, with previously untreated locally
advanced, inoperable or metastatic triple-negative breast cancer (TNBC)
- Individuals whose tumors are programmed cell death ligand 1 (PD-L1) negative at
screening or individuals whose tumors are PD-L1 positive at screening if they
have received an anti-PD-(L)1 inhibitor in the (neo) adjuvant setting or if
they cannot be treated with a checkpoint inhibitor due to a comorbidity
- Centrally confirmed TNBC and PD-L1 status on fresh or archival tissue
- Individuals must have completed treatment for Stage I-III breast cancer, if
indicated, and = 6 months must have elapsed (with the exception of endocrine
therapy) between completion of treatment with curative intent and first
documented local or distant disease recurrence
- Individuals presenting with de novo metastatic TNBC are eligible
- Measurable disease based on computed tomography (CT) or magnetic resonance imaging
(MRI) in accordance with per Response Evaluation Criteria in Solid Tumors (RECIST)
Version 1.1. as evaluated locally
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Demonstrates adequate organ function
- Male individuals and female individuals of childbearing potential who engage in
heterosexual intercourse must agree to use protocol-specified method(s) of
contraception
- Individuals with human immunodeficiency virus (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 systemic anticancer treatment within the previous 6 months or radiation
therapy within 2 weeks prior to enrollment
- Have not recovered from adverse events (AEs) due to a previously administered agent
at the time study entry
- 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
- Previously received topoisomerase 1 inhibitors or antibody drug conjugates
containing a topoisomerase inhibitor
- Active second malignancy
- Active serious infection requiring antibiotics
- Positive for HIV-1 or 2 with a history of Kaposi sarcoma and/or Multicentric
Castleman Disease
- Active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection
Note: Other protocol defined Inclusion/Exclusion criteria may apply. (ICTRP)
nicht verfügbar
Primäre und sekundäre Endpunkte
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;Change from Baseline in the Physical Functioning Domain as Measured by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire, Core Questionnaire, Version 3.0 (EORTC QLQ-C30).;Time to Deterioration (TTD) of Fatigue Scale of the EORTC QLQ-C30 (ICTRP)
Registrierungsdatum
nicht verfügbar
Einschluss des ersten Teilnehmers
nicht verfügbar
Sekundäre Sponsoren
nicht verfügbar
Weitere Kontakte
Gilead Study Director;Gilead Clinical Study Information Center, GileadClinicalTrials@gilead.com, 1-833-445-3230 (GILEAD-0), Gilead Sciences, (ICTRP)
Sekundäre IDs
2021-005743-79, DOH-27082022-7958, jRCT2041220122, CTR20234162, 2023-504195-14, GS-US-592-6238 (ICTRP)
Angaben zur Verfügbarkeit von individuellen Teilnehmerdaten
nicht verfügbar
Weitere Informationen zur Studie
https://clinicaltrials.gov/ct2/show/NCT05382299 (ICTRP)
Ergebnisse der Studie
Zusammenfassung der Ergebnisse
nicht verfügbar
Link zu den Ergebnissen im Primärregister
nicht verfügbar