A Study to Test Inavolisib Treatments in Participants With Early-Stage, PIK3CA-Mutated Breast Cancer
Sponsor: Hoffmann-La Roche
Sponsor score: 40
ClinicalTrials ID:NCT07054190
This clinical trial assesses the safety and efficacy of inavolisib combined with ribociclib and letrozole in participants with untreated, PIK3CA-mutated, Stage II-III ER-positive, HER2-negative breast cancer. Eligible participants must have operable or inoperable invasive cancer, be candidates for neoadjuvant treatment, and have a confirmed PIK3CA mutation.
Patient Parameters
| Parameter | Options |
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Program Overview
This study will evaluate the safety and efficacy of inavolisib combination therapies in participants with untreated, PIK3CA-mutated, Stage II-III, estrogen receptor (ER)-positive, Human Epidermal Growth Factor Receptor 2 (HER2)-negative breast cancer (BC).
Eligibility Criteria
Inclusion Criteria
- Histologically confirmed operable or inoperable invasive Stage II-III BC according to American Joint Committee on Cancer (AJCC) TNM staging classification
- Candidate for neoadjuvant treatment and considered appropriate for endocrine combination therapy
- Willingness to undergo breast surgery (mastectomy or breast-conserving surgery) after neoadjuvant treatment (unless inoperable)
- Documented ER-positive tumor in accordance with current American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) guidelines
- Documented HER2-negative tumor in accordance with current ASCO/CAP guidelines
- Documented Ki-67 score >=5% as per local assessment
- Confirmed PIK3CA mutation
Exclusion Criteria
- Stage IV (metastatic) BC
- Inflammatory BC (cT4d)
- Bilateral invasive BC
- History of ductal carcinoma in situ or lobular carcinoma in situ if they have received any systemic therapy for treatment or radiation therapy to the ipsilateral breast
- Previous systemic or local treatment for the primary BC currently under investigation (including excisional biopsy or any other surgery of the primary tumor and/or axillary lymph nodes, including sentinel lymph node biopsy, radiotherapy, cytotoxic, and endocrine treatments)
- Type 2 diabetes requiring ongoing systemic treatment at the time of study entry; or any history of Type 1 diabetes
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Community Clinical Trials | 92868 | Orange | California |
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