STUDY ASSESSING THE EFFICACY AND SAFETY OF ALPELISIB PLUS FULVESTRANT IN MEN AND POSTMENOPAUSAL WOMEN WITH ADVANCED BREAST CANCER WHICH PROGRESSED ON OR AFTER AROMATASE INHIBITOR TREATMENT.
- Conditions
- -C50 Malignant neoplasm of breastMalignant neoplasm of breastC50
- Registration Number
- PER-044-15
- Lead Sponsor
- OVARTIS BIOSCIENSES PERU S.A.,
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 9
1. Patient is an adult ≥ 18 years old at the time of informed consent and has signed informed consent before any trial related activities and according to local guidelines.
2. Patient has adequate FFPE tumor tissue for the analysis of PIK3CA mutational status by a Novartis designated laboratory. One tumor block (preferred) or 15 to 20 slides (15 slides
minimum from a surgical specimen, 20 slides minimum from a biopsy) are requested.
3. Patient has identified PIK3CA status (mutant or non-mutant; determined by a Novartis
designated laboratory on the FFPE sample or slides).
4. If female, then the patient is postmenopausal. Postmenopausal status is defined either by:
•Prior bilateral oophorectomy
•Age ≥60
•Age <60 and amenorrheic for 12 or more months in the absence of chemotherapy,
tamoxifen, toremifene, or ovarian suppression and Follicle-stimulating Hormone
(FSH) and estradiol in the postmenopausal range per local normal range.
5. Patient has radiological or objective evidence of recurrence or progression.
6. Patient has a histologically and/or cytologically confirmed diagnosis of ER+ and/or PgR+ breast cancer by local laboratory.
The complete list of inclusion criteria is in section 5.2 of the protocol
1. Patient with symptomatic visceral disease or any disease burden that makes the patient
ineligible for endocrine therapy per the investigator’s best judgment.
2. Patient has received prior treatment with chemotherapy (except for neoadjuvant/ adjuvant chemotherapy), fulvestrant, any PI3K, mTOR or AKT inhibitor.
3. Patient has a known hypersensitivity to alpelisib or fulvestrant, or to any of the excipients of alpelisib or fulvestrant.
4. Patient with inflammatory breast cancer at screening.
5. Patient is concurrently using other anti-cancer therapy.
6. Patient has had surgery within 14 days prior to starting study drug or has not recovered
from major side effects.
7. Patient has not recovered from all toxicities related to prior anticancer therapies to NCI
CTCAE version 4.03 Grade ≤1. Exception to this criterion: patients with any grade of alopecia are allowed to enter the study.
8. Patients with Child pugh score B or C.
9. Patient has received radiotherapy ≤ 4 weeks or limited field radiation for palliation ≤ 2
weeks prior to randomization, and who has not recovered to grade 1 or better from related
side effects of such therapy (with the exception of alopecia) and/or from whom ≥ 25% of the bone marrow was irradiated.
The complete list of inclusion criteria is in section 5.3 of the protocol
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method