Clinical trial/study to evaluate safety and efficacy in Breast Cancer patients.
- Conditions
- Health Condition 1: C509- Malignant neoplasm of breast of unspecified site
- Registration Number
- CTRI/2023/08/056489
- Lead Sponsor
- F HoffmannLa Roche Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
Histologically or cytologically confirmed and documented human epidermal growth factor receptor 2 positive/estrogen receptor positive adenocarcinoma of the breast with metastatic or locally-advanced disease not amenable to curative resection.
Complete a minimum of four cycles of induction therapy
Achieve a minimum of stable disease according to RECIST v1.1 at the last tumor assessment during the induction therapy phase
LVEF of more than equal to 50 percent at the last assessment during the induction therapy phase
Previous systemic non-hormonal anti-cancer therapy in the metastatic breast cancer or advanced breast cancer setting. Note: Up to one line of single-agent endocrine therapy given in the metastatic or locally advanced setting will be allowed.
Prior treatment with a selective estrogen receptor degrader
Previous treatment with approved or investigative anti HER2 agents in any breast cancer treatment setting, except Phesgo, ado-trastuzumab emtansine, lapatinib, and neratinib in the neoadjuvant or adjuvant setting
Disease progression within 6 months of receiving trastuzumab, with or without pertuzumab, or ado-trastuzumab emtansine in the adjuvant setting
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Progression-Free Survival, as Determined by the Investigator According to RECIST v1.1 <br/ ><br>Timepoint: From randomization for maintenance therapy to the first occurrence of disease progression or death from any cause, whichever occurs first (up to 50 months) <br/ ><br>
- Secondary Outcome Measures
Name Time Method Clinical Benefit Rate, as Determined by the Investigator According to RECIST v1.1Timepoint: From randomization for maintenance therapy to disease progression or death (up to 50 months);Mean Role Functioning Score Over Time, as Assessed Using the European Organisation for Research and Treatment of Cancer Quality of Life-Core 30 (EORTC QLQ-C30) QuestionnaireTimepoint: Maintenance Cycles 1 (Baseline), 3, 6, 9, 12, 15, 18, 24, 30, 36, 39, 48, 57, 66, 75, 84 (1 cycle is 21 days) and to treatment discontinuation, then once every 6 months and once every year for Follow-up Years 1-2 and 3-5, respectively (up to 10 years);Objective Response Rate, as Determined by the Investigator According to RECIST v1.1Timepoint: From randomization for maintenance therapy to disease progression or death (up to 50 months);Overall SurvivalTimepoint: From randomization for maintenance therapy to death from any cause (up to 122 months)