CompletedPhase 2

Study to Evaluate the Effect of Metformin in the Prevention of HG in HR[+]/HER2[-] PIK3CA-mut Advanced BC Patients

Spain69 participantsStarted 2020-10-23

Plain-language summary

Men and post- or induced menopausal women with ER\[+\] and/or PgR\[+\], HER2\[- \] advanced BC, with centrally-confirmed PI3KCAMut who progressed to an aromatase inhibitor (AI) regimen.

Who can participate

Age range18 Years

SexALL

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

✓. Signed Informed Consent Form (ICF)prior to participation in any study- related activities.
✓. Men, pre-menopausal or post-menopausal women ≥ 18 years of age at the time of signing ICF.
✓. Men and pre-menopausal women should have been treated with a luteinizing hormone-releasing hormone (LHRH) analogue at least one week prior to study entry. Post-menopausal women are defined as per the following criteria:
✓. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
✓. Histologically proven diagnosis of advanced breast cancer (ABC, loco regionally recurrent not amenable to curative therapy or metastatic disease).
✓. Confirmed diagnosis of estrogen receptor (ER)\[+\] and/or progesterone receptor (PR)\[+\] (with ≥1% positive stained cells according to National Comprehensive Cancer Network \[NCCN\] and American Society of Clinical Oncology \[ASCO\] guidelines) and human epidermal growth factor receptor 2 (HER2)-negative (0 or 1+ by immunohistochemistry \[IHC\] or 2+ and negative by in situ hybridization \[ISH\] test) breast cancer in the advanced setting.
✓. Measurable or evaluable disease as per Response Evaluation Criteria in Solid Tumors (RECIST) version (v.)1.1 criteria. Patients with bone- only metastases are eligible.
✓. Presence of phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha (PIK3CA)-mutated (PIK3CAMut) determined on the most recent tumor tissue specimen (frozen or formalin-fixed paraffin- embedded \[FFPE\]) or plasma circulating tumor DNA (ctDNA).

Exclusion criteria

✕. Prior treatment with a phosphatidylinositol 3-kinase (PI3K), AKT, or mammalian target of the rapamycin (mTOR) inhibitor. Prior treatment with a cyclin-dependent kinase 4/6 inhibitor (CDK4/6i) is allowed.
✕. Known hypersensitivity to alpelisib, fulvestrant, letrozole, exemestane, tamoxifen or to any of their excipients.
✕. Patients treated with insulin.
✕. Cohort A and B; Established diagnosis of type 1 or 2 diabetes mellitus (DM) requiring anti-diabetic drugs. Patients with an impaired FPG or HbA1c as per inclusion criterion #14 are eligible to enter the cohort B if no anti-diabetic drug were received in the last 14 days prior to the start of study treatment.
✕. Cohort C;
✕. Inflammatory breast cancer at screening.
✕. Concurrent malignancy or malignancy within first 3 years of start of study treatment, except for adequately treated, basal or squamous cell carcinoma, non-melanomatous skin cancer, or curatively resected cervical cancer.
✕. Past medical history of acute or chronic pancreatitis within one year prior to screening.

What they're measuring

Assess the rate of patients with G3-4 hyperglycemia (HG) by CTCAE v4.03 over the first 2 cycles of treatment with alpelisib (BYL719) (Cohorts A and B)

Timeframe: Baseline up tp 15 months

Assess the rate of patients with permanent discontinuation of alpelisib due to related AEs after 8 weeks of treatment with alpelisib plus endocrine therapy and antidiabetic treatment (Cohort C).

Timeframe: Baseline up tp 15 months

Trial details

NCT IDNCT04300790

SponsorMedSIR

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-06-15

View on ClinicalTrials.gov More Breast Cancer trials

Who can participate

Age range18 Years

SexALL

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

✓. Signed Informed Consent Form (ICF)prior to participation in any study- related activities.
✓. Men, pre-menopausal or post-menopausal women ≥ 18 years of age at the time of signing ICF.
✓. Men and pre-menopausal women should have been treated with a luteinizing hormone-releasing hormone (LHRH) analogue at least one week prior to study entry. Post-menopausal women are defined as per the following criteria:
✓. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
✓. Histologically proven diagnosis of advanced breast cancer (ABC, loco regionally recurrent not amenable to curative therapy or metastatic disease).
✓. Confirmed diagnosis of estrogen receptor (ER)\[+\] and/or progesterone receptor (PR)\[+\] (with ≥1% positive stained cells according to National Comprehensive Cancer Network \[NCCN\] and American Society of Clinical Oncology \[ASCO\] guidelines) and human epidermal growth factor receptor 2 (HER2)-negative (0 or 1+ by immunohistochemistry \[IHC\] or 2+ and negative by in situ hybridization \[ISH\] test) breast cancer in the advanced setting.
✓. Measurable or evaluable disease as per Response Evaluation Criteria in Solid Tumors (RECIST) version (v.)1.1 criteria. Patients with bone- only metastases are eligible.
✓. Presence of phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha (PIK3CA)-mutated (PIK3CAMut) determined on the most recent tumor tissue specimen (frozen or formalin-fixed paraffin- embedded \[FFPE\]) or plasma circulating tumor DNA (ctDNA).

Exclusion criteria

✕. Prior treatment with a phosphatidylinositol 3-kinase (PI3K), AKT, or mammalian target of the rapamycin (mTOR) inhibitor. Prior treatment with a cyclin-dependent kinase 4/6 inhibitor (CDK4/6i) is allowed.
✕. Known hypersensitivity to alpelisib, fulvestrant, letrozole, exemestane, tamoxifen or to any of their excipients.
✕. Patients treated with insulin.
✕. Cohort A and B; Established diagnosis of type 1 or 2 diabetes mellitus (DM) requiring anti-diabetic drugs. Patients with an impaired FPG or HbA1c as per inclusion criterion #14 are eligible to enter the cohort B if no anti-diabetic drug were received in the last 14 days prior to the start of study treatment.
✕. Cohort C;
✕. Inflammatory breast cancer at screening.
✕. Concurrent malignancy or malignancy within first 3 years of start of study treatment, except for adequately treated, basal or squamous cell carcinoma, non-melanomatous skin cancer, or curatively resected cervical cancer.
✕. Past medical history of acute or chronic pancreatitis within one year prior to screening.

What they're measuring

Assess the rate of patients with G3-4 hyperglycemia (HG) by CTCAE v4.03 over the first 2 cycles of treatment with alpelisib (BYL719) (Cohorts A and B)

Timeframe: Baseline up tp 15 months

Assess the rate of patients with permanent discontinuation of alpelisib due to related AEs after 8 weeks of treatment with alpelisib plus endocrine therapy and antidiabetic treatment (Cohort C).

Timeframe: Baseline up tp 15 months