OncoMatch/Clinical Trials/NCT07054190
A Study to Test Inavolisib Treatments in Participants With Early-Stage, PIK3CA-Mutated Breast Cancer
Is NCT07054190 recruiting? Yes, currently enrolling (Jun 2026). This Phase 2 trial studies multiple treatments including Inavolisib and Ribociclib for breast cancer.
Treatment: Inavolisib · Ribociclib · Letrozole — 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).
Check if I qualifyExtracted eligibility criteria
Treatments studied
Targeted therapy
Endocrine / hormonal
Cancer type
Breast Carcinoma
Biomarker criteria
Required: PIK3CA mutation
Confirmed PIK3CA mutation
Required: ESR1 overexpression (ER-positive)
Documented ER-positive tumor in accordance with current American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) guidelines
Required: HER2 (ERBB2) wild-type (HER2-negative)
Documented HER2-negative tumor in accordance with current ASCO/CAP guidelines
Required: MKI67 overexpression (Ki-67 score >=5%)
Documented Ki-67 score >=5% as per local assessment
Disease stage
Required: Stage II, III
Excluded: Stage IV
Demographics
Prior therapy
Cannot have received: systemic therapy
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)
Structured fields extracted by AI. May contain errors — verify against the official protocol.
Frequently asked questions
Is NCT07054190 currently recruiting?
Yes, this trial is currently recruiting patients.
Can patients have received prior systemic therapy?
No. This trial requires treatment-naive patients — prior systemic therapy is an exclusion criterion.
Does this trial require PIK3CA?
Yes, PIK3CA mutation is a required biomarker for enrollment.
Does this trial require ESR1?
Yes, ESR1 overexpression is a required biomarker for enrollment.
Does this trial require ERBB2?
Yes, ERBB2 wild-type is a required biomarker for enrollment.
What disease stage is eligible?
Stage II or III is required.
Is this trial open to male patients?
No. This trial enrolls female patients only.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages