A clinical study to investigate the therapeutic benefit and safety of combining alpelisib and fulvestrant in the treatment of postmenopausal women with advanced breast cancer whose disease came back while on or after treatment with an aromatase inhibitor
- Conditions
- Hormone receptor positive, HER2-negative advanced breast cancerMedDRA version: 18.0Level: LLTClassification code 10072737Term: Advanced breast cancerSystem Organ Class: 100000004864Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2015-000340-42-ES
- Lead Sponsor
- ovartis Farmacéutica, S.A.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 820
1. Patient is an adult ? 18 years old at the time of informed consent
2. Patient has adequate FFPE tumor tissue for the analysis of PIK3CA mutational status
3. Patient has identified PIK3CA status
4. If female, then the patient is postmenopausal
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
7. Patient has HER2-negative breast cancer
8. Patient has either measurable disease (at least one measurable lesion as per RECIST 1.1) or at least one predominantly lytic bone lesion
9. Patient has advanced (loco regionally recurrent not amenable to curative therapy or metastatic) breast cancer
10. Patient has recurrence or progression of disease during or after AI therapy (i.e. letrozole, anastrozole, exemestane)
Further inclusion criteria and details are described in the protocol
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 246
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 574
1. Patient with symptomatic visceral disease or any prohibitive disease burden
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 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 except alopecia
Further exclusion criteria and details are described in the protocol
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method