A Study Evaluating the Efficacy and Safety of inavolisib Plus Palbociclib and Fulvestrant versus Placebo Plus Palbociclib and Fulvestrant in Patients with PIK3CA-Mutated, Hormone Receptor-Positive, HER2-Negative Locally Advanced or Metastatic Breast Cancer.

Phase 1

• Conditions: Breast cancer; MedDRA version: 20.0Level: LLTClassification code 10027475Term: Metastatic breast cancerSystem Organ Class: 100000004864; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2019-002455-42-DK
• Lead Sponsor: F. Hoffmann-La Roche Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-08-24
• Last Update Posted: 9 January 2023

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 400

Inclusion Criteria

- Women or men >= 18 years of age
- Receiving LHRH agonist therapy for at least 2 weeks prior to Day 1 of Cycle 1 if pre/peri-menopausal
- Confirmed diagnosis of HR+/HER2-negative breast cancer
- Metastatic or Locally Advanced disease not amenable to curative therapy
- Confirmation of biomarker eligibility (detection of specified mutation(s) of PIK3CA via specified test)
- Consent to provide fresh or archival tumor tissue specimen
- Progression of disease during adjuvant endocrine treatment or within 12 months of completing adjuvant endocrine therapy with an aromatase inhibitor or tamoxifen
- Measurable disease per Response Evaluation Criteria in Solid Tumors, Version 1.1. Evaluable bone-only” disease is not eligible; bone-only” disease with at least one measurable, soft-tissue component per RECIST v1.1 may be eligible
- Eastern Cooperative Oncology Group Performance Status of 0 or 1
- Life expectancy of > 6 months
- Adequate hematologic and organ function within 14 days prior to initiation of study treatment
- Ability, in the investigator’s judgment, and willingness to comply with all study-related procedures, including completion of patient-reported endpoints
- For patients enrolled in China: Current resident of mainland China and must be of Chinese ancestry
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 280
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 120

Exclusion Criteria

- Metaplastic breast cancer
- Any history of leptomeningeal disease or carcinomatous meningitis
- Any prior systemic therapy for metastatic breast cancer
- Prior treatment with fulvestrant or any selective estrogen-receptor degrader, with the exception of patients that have received fulvestrant or any selective estrogen receptor degrader as part of neoadjuvant therapy only and with treatment duration of no longer than 6 months
- Prior treatment with any PI3K, AKT, or mTOR inhibitor, or any agent whose mechanism of action is to inhibit the PI3K-AKT-mTOR pathway
- Type 2 diabetes requiring ongoing systemic treatment at the time of study entry; or any history of Type 1 diabetes
- Inability or unwillingness to swallow pills or receive intramuscular injections
- Known and untreated, or active CNS metastases. Patients with a history of treated CNS metastases may be eligible
- Uncontrolled pleural effusion, pericardial effusion, or ascites
- Active inflammatory or infectious conditions in either eye, or history of idiopathic or autoimmune associated uveitis in either eye
- Symptomatic active lung disease, or requiring daily supplemental oxygen
- History of inflammatory bowel disease or active bowel inflammation
- Anti-cancer therapy within 2 weeks before study entry
- Investigational drug(s) within 4 weeks before randomization
- Prior radiotherapy to >= 25% of bone marrow, or hematopoietic stem cell or bone marrow transplantation
- History of other malignancy within 5 years prior to screening, except for cancers with very low risk of recurrence including, but not limited to, appropriately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, or Stage I uterine cancer
- History of or active clinically significant cardiovascular dysfunction
- Chronic corticosteroid therapy or immunosuppressants
- Pregnant, lactating, or breastfeeding, or intending to become pregnant during the study or within 60 days after the final dose of study treatment
- Major surgical procedure, or significant traumatic injury, within 28 days prior to Day 1 of Cycle 1

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified