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NCT07054190 | RECRUITING | Breast Cancer

A Study to Test Inavolisib Treatments in Participants With Early-Stage, PIK3CA-Mutated Breast Cancer
Sponsor:

Hoffmann-La Roche

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).

Condition or disease

Breast Cancer

Intervention/treatment

Inavolisib

Ribociclib

Letrozole

Phase

PHASE2

Study Type : INTERVENTIONAL
Estimated Enrollment : 60 participants
Masking : NONE
Primary Purpose : TREATMENT
Official Title : A Phase II, Open-Label, Multicenter Study Evaluating the Safety and Efficacy of Neoadjuvant Treatment With Inavolisib Combinations in Patients With Untreated, Early-stage, PIK3CA-Mutated Breast Cancer
Actual Study Start Date : 2025-09-30
Estimated Primary Completion Date : 2027-03-31
Estimated Study Completion Date : 2027-11-08

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: FEMALE
Accepts Healthy Volunteers:
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
A Study to Test Inavolisib Treatments in Participants With Early-Stage, PIK3CA-Mutated Breast Cancer

Location Details

NCT07054190

Please Choose a site

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

Canada, Quebec

Center Hospitalier de l'Iniversité de Montreal (CHUM)

Montreal, Quebec, Canada, H2X 0C2

RECRUITING

Canada, Quebec

Jewish General Hospital

Montreal, Quebec, Canada, Hat 1 e

RECRUITING

Canada, Quebec

McGill University Health Center

Montreal, Quebec, Canada, H4A 3J1

RECRUITING

South Korea,

Asan Medical Center.

Seoul, South Korea, 05505