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

NCT07054190

RecruitingPhase 2

Sponsor: Hoffmann-La Roche

Conditions: Breast Cancer

Interventions: Inavolisib, Ribociclib, Letrozole

Countries: United States, Argentina, Brazil, Canada, Germany, South Korea, Spain

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 overview

Sex: FEMALE

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

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 (33)
  • Los Angeles, California, United States
  • Orange, California, United States
  • Germantown, Tennessee, United States
  • Morgantown, West Virginia, United States
  • Buenos Aires, Argentina
  • Buenos Aires, Argentina
  • Ciudad Autonoma Buenos Aires, Argentina
  • Goiânia, Goiás, Brazil
  • Recife, Pernambuco, Brazil
  • Porto Alegre, Rio Grande do Sul, Brazil
  • São Paulo, São Paulo, Brazil
  • Toronto, Ontario, Canada
  • Montreal, Quebec, Canada
  • Montreal, Quebec, Canada
  • Montreal, Quebec, Canada
  • Berlin, Germany
  • Berlin, Germany
  • Dresden, Germany
  • Essen, Germany
  • Heidelberg, Germany
  • Paderborn, Germany
  • Schwerin, Germany
  • Seoul, South Korea
  • Seoul, South Korea
  • Seoul, South Korea
  • Seoul, South Korea
  • Barcelona, Spain
  • Barcelona, Spain
  • Madrid, Spain
  • Madrid, Spain
  • + 3 more on CT.gov