Breast Cancer Clinical Trial
Official title:
A Phase 1-2 Multicenter, Open Label Trial of H3B-6545, a Covalent Antagonist of Estrogen Receptor Alpha, in Women With Locally Advanced or Metastatic Estrogen Receptor-positive, HER2 Negative Breast Cancer
Verified date | March 2023 |
Source | Eisai Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The primary purpose of phase 1 portion of this study is to determine the maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D) of H3B-6545 in women with locally advanced or metastatic estrogen receptor (ER)-positive, human epidermal growth factor 2 (HER2)-negative breast cancer. The primary purpose of phase 2 portion of this study is to estimate the efficacy of H3B-6545 in terms of best overall response rate, duration of response (DoR), clinical benefit rate (CBR), disease control rate (DCR), progression-free survival (PFS), and overall survival (OS) in all participants with ER-positive, HER2-negative breast cancer and in those with and without ER alpha mutation (including a clonal estrogen receptor 1 gene [ESR1] Y537S mutation).
Status | Completed |
Enrollment | 206 |
Est. completion date | October 26, 2023 |
Est. primary completion date | October 26, 2023 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: 1. Pre- or post-menopausal women. 2. ER-positive, HER2-negative breast cancer that is advanced or metastatic. 3. Progressed on prior therapy. Multiple prior lines of therapy allowed in Phase 1 and 2. Participants under amendment 6 (or subsequent amendments) must have received prior cyclin-dependent kinase (CDK4/6) inhibitor therapy. Up to one prior chemotherapy in the metastatic setting is allowed. 4. A recent archival tumor tissue obtained within 6 months prior to enrollment or a fresh tumor biopsy must be provided. A second biopsy after initiating trial therapy is not required. 5. Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1. 6. Adequate bone marrow and organ function. 7. Participants under amendment 6 (or subsequent amendments) must have measurable disease at baseline as per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria. 8. Participants under amendment 6 (or subsequent amendments) must have ESR1 Y537S mutation in absence of ESR1 D538G mutation as per the results of a central laboratory from a Nucleic Acids Whole Blood sample. Exclusion Criteria: 1. Participants must have at least one measurable lesion. 2. Participant with inflammatory breast cancer. 3. Participant has received more than one prior chemotherapy regimen for metastatic disease (Phase 2 only). 4. Females of childbearing potential who are unable or unwilling to follow adequate contraceptive measures. |
Country | Name | City | State |
---|---|---|---|
France | Edog - Ico - Ppds | Angers | |
France | Hopital Jean Minjoz | Besançon | |
France | Centre Jean Perrin | Clermont-Ferrand | |
France | Centre Oscar Lambret | Lille | |
France | Hôpital de la Pitié Salpétrière | Paris | |
France | Hôpital Saint Louis | Paris | |
France | EDOG - Centre Eugene Marquis Centre Regional de Lutte Contre Le Cancer - PPDS | Rennes | |
France | EDOG Institut de Cancerologie de l'Ouest - PPDS | St. Herblain | |
France | Institut de Cancérologie Strasbourg Europe | Strasbourg | |
France | Institut Gustave Roussy | Villejuif Cedex | |
United Kingdom | Velindre Cancer Centre | Cardiff | |
United Kingdom | The Royal Marsden NHS Foundation Trust | Chelsea | London |
United Kingdom | Barts Health NHS Trust | London | |
United Kingdom | Sarah Cannon Research Institute | London | |
United Kingdom | Christie Hospital | Manchester | |
United Kingdom | The Royal Marsden NHS Foundation Trust | Sutton | |
United States | University of Michigan | Ann Arbor | Michigan |
United States | University of Colorado - Cancer Center | Aurora | Colorado |
United States | Johns Hopkins Sidney Kimmel Comprehensive Cancer Center | Baltimore | Maryland |
United States | Massachusetts General Hospital | Boston | Massachusetts |
United States | University of North Carolina | Chapel Hill | North Carolina |
United States | Parkland Health and Hospital System | Dallas | Texas |
United States | UT Southwestern Medical Center | Dallas | Texas |
United States | Holy Cross Hospital Inc | Fort Lauderdale | Florida |
United States | Florida Cancer Specialists South | Fort Myers | Florida |
United States | Western Regional Medical Center, Inc., DBA Cancer Treatment Centers of America, Phoenix | Goodyear | Arizona |
United States | Research Medical Center | Kansas City | Missouri |
United States | Saint Luke's Cancer Institute | Kansas City | Missouri |
United States | Comprehensive Cancer Center of Nevada | Las Vegas | Nevada |
United States | University of California Los Angeles | Los Angeles | California |
United States | Tennessee Oncology | Nashville | Tennessee |
United States | Southeastern Regional Medical Center, Inc., DBA Cancer Treatment Centers of America, Atlanta | Newnan | Georgia |
United States | Florida Cancer Specialists North | Saint Petersburg | Florida |
United States | Huntsman Cancer Institute at The University of Utah | Salt Lake City | Utah |
United States | University of California San Francisco | San Francisco | California |
United States | Florida Cancer Specialists and Research Institute | Sarasota | Florida |
United States | Tyler Oncology/Oncology PA | Tyler | Texas |
United States | Carle Cancer Center | Urbana | Illinois |
United States | Midwestern Regional Medical Center, Inc., DBA Cancer Treatment Centers of Americal, Chicago | Zion | Illinois |
Lead Sponsor | Collaborator |
---|---|
Eisai Inc. |
United States, France, United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of Participants with Dose-limiting Toxicities (DLTs) | Phase 1 Cycle 1 (28 days) | ||
Primary | Number of Participants with Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | Phase 1 and 2 continuously throughout the study until 28 days after treatment discontinuation (up to 36 months) | ||
Secondary | Area under the Plasma Concentration-time Curve from Time 0 Through the Last Measurable Point (AUC0-t) of H3B-6545 | Phase 1, Cycle 1 (28-day cycles): Days 1 and 15 pre-dose and at multiple time points (up to 24 hours) post-dose; or Phase 2 Cycle 1 (28-day cycles): Days 15 or 22 pre-dose and at multiple time points (up to 24 hours) post-dose | ||
Secondary | Mean Maximum Observed Plasma Concentration (Cmax) of H3B-6545 | Phase 1, Cycle 1 (28-day cycles): Days 1 and 15 (pre-dose and at multiple time points (up to 24 hours) post-dose; or Phase 2 Cycle 1 (28-day cycles): Days 15 or 22 pre-dose and at multiple time points (up to 24 hours) post-dose | ||
Secondary | Time of Maximum Observed Plasma Concentration (tmax) of H3B-6545 | Phase 1, Cycle 1 (28-day cycles): Days 1 and 15 pre-dose and at multiple time points (up to 24 hours) post-dose; or Phase 2 Cycle 1 (28-day cycles): Days 15 or 22 pre-dose and at multiple time points (up to 24 hours) post-dose | ||
Secondary | Objective Response Rate (ORR) | Phase 1 and 2 up to approximately 36 months | ||
Secondary | Duration of Response (DoR) | Phase 1 and 2 up to approximately 36 months | ||
Secondary | Disease Control Rate (DCR) | Phase 1 and 2 up to approximately 36 months | ||
Secondary | Clinical Benefit Rate (CBR) | Phase 1 and 2 up to approximately 36 months | ||
Secondary | Progression-free survival (PFS) | Phase 1 and 2 up to approximately 36 months | ||
Secondary | Overall Survival (OS) | Phase 1 and 2 up to approximately 36 months |
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