Breast Cancer
Conditions
Brief summary
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).
Interventions
DRUGInavolisib
Inavolisib will be administered as per the schedule specified in the arms
DRUGRibociclib
Ribociclib will be administered as per the schedule specified in the arms
DRUGLetrozole
Letrozole will be administered as per the schedule specified in the arms
DRUGGiredestrant
Giredestrant will be administered as per the schedule specified in the arms
Sponsors
Hoffmann-La Roche
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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, and 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of Participants with Adverse Events (AEs) | From first dose up to 30 days after last dose (approximately 8 months) |
Secondary
| Measure | Time frame |
|---|---|
| Percentage of Participants with Total Pathological Complete Response (pCR) | Up to approximately 8 months |
| Percentage of Participants with Objective Response Rate (ORR), According to Modified Response Evaluation Criteria in Solid Tumors, Version 1.1 (mRECIST v1.1) | Up to approximately 8 months |
| Change From Baseline in Ki-67 Levels by Immunohistochemistry (IHC) | Baseline, Day 22 of Cycle 1 and at Surgery (up to approximately 8 months). One cycle = 28 days |
| Percentage of Participants Reporting Symptoms in Patient-Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) Questionnaire | Up to approximately 8 months |
| Percentage of Participants Reporting Each Response Option at Each Time Point for the Treatment Side-Effect Bother Item (GP5) From the Functional Assessment of Cancer Therapy - General (FACT-G) Questionnaire | Up to approximately 8 months |
| Change from Baseline in Symptomatic Treatment-Related Toxicities as Assessed Through use of the PRO-CTCAE | Baseline, up to approximately 8 months |
| Change from Baseline in Treatment Side-Effect Bother as Assessed Through use of the FACT-G GP5 Item | Baseline, up to approximately 8 months |
Countries
Argentina, Brazil, Canada, Germany, South Korea, Spain, United States
Contacts
CONTACTReference Study ID Number: BO45853 https://forpatients.roche.com/ No attachments to email below.
CONTACTFastest response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry
STUDY_DIRECTORClinical Trials
Hoffmann-La Roche
Outcome results
None listed