| Titre |
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 |
| Protocole ID |
BO45853 |
| ClinicalTrials.gov ID |
NCT07054190 |
| Type(s) de cancer |
Sein |
| Phase |
Phase II |
| Type étude |
Clinique |
| Médicament |
Inavolisib |
| Institution |
CENTRE HOSPITALIER DE L'UNIVERSITE DE MONTREAL
|
| Ville |
Montréal |
| Investigateur(trice) principal(e) |
Dr Rami Younan
|
| Coordonnateur(trice) |
Ana Lydia Tkalec
514-890-8000 poste 14186
|
| Statut |
 Actif en recrutement |
| Date d'activation |
12-08-2025 |
| Critètes d'éligibilité |
- 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
|
| Critètes d'exclusion |
- 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
|
Groupe d'étude en oncologie du Québec