EUCTR2021-001966-39-PT
Active, not recruiting
Phase 1
EPIK-B5: A Phase III, randomized, double-blind, placebo-controlled study of alpelisib (BYL719) in combination with fulvestrant for men and postmenopausal women with HR-positive, HER2-negative advanced breast cancer with a PIK3CA mutation, who progressed on or after aromatase inhibitor and a CDK4/6 inhibitor - EPIK-B5
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- ovartis Pharma AG
- Enrollment
- 234
- Status
- Active, not recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •\- Participant is an adult \= 18 years old at the time of informed consent and has signed informed consent before any trial related activities and according to local guidelines
- •\- Participant has a histologically and/or cytologically confirmed diagnosis of ER\+ and/or PgR\+ breast cancer by local laboratory.
- •\- Participant has HER2\-negative breast cancer defined as a negative in situ hybridization test or an IHC status of 0, 1\+ or 2\+. If IHC is 2\+, a negative in situ hybridization (Fluorescent in situ hybridization (FISH), Chromogenic in situ hybridization (CISH), or Silver\-enhanced in situ hybridization (SISH)) test is required by local laboratory testing
- •\- Participant has at least one measurable lesion as per RECIST v1\.1 criteria as assessed by Investigator (a lesion at a previously irradiated site may only be counted as a target lesion if there is clear sign of progression since the irradiation).
- •\- Participant has recurrence or progression of disease during or after combined AI (i.e. letrozole, anastrozole, exemestane) and CDK4/6 inhibitor therapy. The combined AI and CDK4/6 inhibitor therapy does not need to be the latest treatment regimen (including adjuvant setting).
- •\- Participant has received \= 2 prior lines of systemic therapies overall in the metastatic setting, of which a maximum of 1 line of prior treatment with chemotherapy (except for neoadjuvant/ adjuvant chemotherapy) is permitted.
- •\- The presence of PIK3CA mutation(s) determined in tumor tissue prior to enrollment either by a Novartis designated laboratory or in tumor tissue or plasma ctDNA by a local laboratory using a Food and Drug Administration (FDA)\-approved PIK3CA Companion Diagnostics (CDx) test for alpelisib or the CE\-IVD QIAGEN Therascreen® PIK3CA RGQ PCR test.
- •\- If female, then the participant must be in postmenopausal status
- •Further inclusion criteria and details are described in the protocol
- •Are the trial subjects under 18? no
Exclusion Criteria
- •\- Participant with symptomatic visceral disease or any disease burden that makes the participant ineligible for endocrine therapy (ET) per the investigator’s best judgment.
- •\- Participant who relapsed with documented evidence of progression more than 12 months from completion of (neo)adjuvant endocrine/ endocrine\- based therapy with no treatment for metastatic disease
- •\- Participant has received prior treatment with fulvestrant, any oral selective estrogen receptor degrader (SERD), any Phosphatidylinositol\- 3\-Kinase (PI3K), mammalian Target of Rapamycin (mTOR) or Protein Kinase B (AKT) inhibitor
- •Further exclusion criteria and details are described in the protocol
Outcomes
Primary Outcomes
Not specified
Similar Trials
Active, not recruiting
Phase 1
A clinical study to assess the efficacy of alpelisib plus fulvestrant in participants with HR-positive, HER2-negative, advanced breast cancer after treatment with a CDK4/6 inhibitor and an aromatase inhibitorHormone receptor positive, HER2-negative advanced breast cancerMedDRA version: 21.1Level: LLTClassification code 10072737Term: Advanced breast cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]EUCTR2021-001966-39-PLovartis Pharma AG234
Active, not recruiting
Phase 1
A clinical study to assess the efficacy of alpelisib plus fulvestrant in participants with HR-positive, HER2-negative, advanced breast cancer after treatment with a CDK4/6 inhibitor and an aromatase inhibitorHormone receptor positive, HER2-negative advanced breast cancerMedDRA version: 21.1Level: LLTClassification code 10072737Term: Advanced breast cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]EUCTR2021-001966-39-DKovartis Pharma AG234
Active, not recruiting
Phase 1
A clinical study to assess the efficacy of alpelisib plus fulvestrant in participants with HR-positive, HER2-negative, advanced breast cancer after treatment with a CDK4/6 inhibitor and an aromatase inhibitorHormone receptor positive, HER2-negative advanced breast cancerMedDRA version: 21.1Level: LLTClassification code 10072737Term: Advanced breast cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]EUCTR2021-001966-39-DEovartis Pharma AG234
Active, not recruiting
Phase 1
A clinical study to assess the efficacy of alpelisib plus fulvestrant in participants with HR-positive, HER2-negative, advanced breast cancer after treatment with a CDK4/6 inhibitor and an aromatase inhibitorHormone receptor positive, HER2-negative advanced breast cancerMedDRA version: 21.1Level: LLTClassification code 10072737Term: Advanced breast cancerSystem Organ Class: 100000004864Therapeutic area: Diseases [C] - Cancer [C04]EUCTR2021-001966-39-ITOVARTIS PHARMA AG305
Active, not recruiting
Phase 1
A clinical study to assess the efficacy of alpelisib plus fulvestrant in participants with HR-positive, HER2-negative, advanced breast cancer after treatment with a CDK4/6 inhibitor and an aromatase inhibitorHormone receptor positive, HER2-negative advanced breast cancerMedDRA version: 21.1Level: LLTClassification code 10072737Term: Advanced breast cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]EUCTR2021-001966-39-FIovartis Pharma AG234