CompletedPhase 1/2

Trial of H3B-6545, in Women With Locally Advanced or Metastatic Estrogen Receptor-positive, HER2 Negative Breast Cancer

United States151 participantsStarted 2017-08-23

Plain-language summary

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).

Who can participate

Age range18 Years

SexFEMALE

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Pre- or post-menopausal women.
✓. ER-positive, HER2-negative breast cancer that is advanced or metastatic.
✓. 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.
✓. 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.
✓. Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1.
✓. Adequate bone marrow and organ function.
✓. 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.
✓. 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

What they're measuring

Phase 1: Number of Participants With Dose-limiting Toxicities (DLTs)

Timeframe: Cycle 1 (Cycle length=28 days)

Phase 1 and Phase 2: Objective Response Rate (ORR)

Timeframe: Phase 1 and Phase 2: From the first dose of study drug to the first date of documentation of progressive disease (PD) or death, whichever occurred first (up to 33 months)

Phase 1 and Phase 2: Duration of Response (DoR)

Timeframe: Phase 1 and Phase 2: From the first dose of study drug to the first date of documentation of PD or death, whichever occurred first (up to 33 months)

Phase 1 and Phase 2: Disease Control Rate (DCR)

Timeframe: Phase 1 and Phase 2: From the first dose of study drug to the first date of documentation of PD or death, whichever occurred first (up to 33 months)

Phase 1 and Phase 2: Clinical Benefit Rate (CBR)

Timeframe: Phase 1 and Phase 2: From the first dose of study drug to the first date of documentation of PD or death, whichever occurred first (up to 33 months)

Phase 1 and Phase 2: Progression-free Survival (PFS)

Timeframe: Phase 1 and Phase 2: From the first dose of study drug to the first date of documentation of PD or death, whichever occurred first (up to 33 months)

Trial details

NCT IDNCT03250676

SponsorEisai Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2023-10-26

Results submitted2024-10-25

View on ClinicalTrials.gov More Breast Neoplasms trials

Plain-language summary

Who can participate

Age range18 Years

SexFEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Pre- or post-menopausal women.
✓. ER-positive, HER2-negative breast cancer that is advanced or metastatic.
✓. 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.
✓. 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.
✓. Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1.
✓. Adequate bone marrow and organ function.
✓. 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.
✓. 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

What they're measuring

Phase 1: Number of Participants With Dose-limiting Toxicities (DLTs)

Timeframe: Cycle 1 (Cycle length=28 days)

Phase 1 and Phase 2: Objective Response Rate (ORR)

Timeframe: Phase 1 and Phase 2: From the first dose of study drug to the first date of documentation of progressive disease (PD) or death, whichever occurred first (up to 33 months)

Phase 1 and Phase 2: Duration of Response (DoR)

Timeframe: Phase 1 and Phase 2: From the first dose of study drug to the first date of documentation of PD or death, whichever occurred first (up to 33 months)

Phase 1 and Phase 2: Disease Control Rate (DCR)

Timeframe: Phase 1 and Phase 2: From the first dose of study drug to the first date of documentation of PD or death, whichever occurred first (up to 33 months)

Phase 1 and Phase 2: Clinical Benefit Rate (CBR)

Timeframe: Phase 1 and Phase 2: From the first dose of study drug to the first date of documentation of PD or death, whichever occurred first (up to 33 months)

Phase 1 and Phase 2: Progression-free Survival (PFS)

Timeframe: Phase 1 and Phase 2: From the first dose of study drug to the first date of documentation of PD or death, whichever occurred first (up to 33 months)