A phase III randomized, double blind placebo controlled study of BKM120 with fulvestrant, in postmenopausal women with hormone receptor-positive HER2-negative locally advanced or metastatic breast cancer which progressed on or after aromatase inhibitor treatment (CBKM120F2302)
- Conditions
- 10006291breast cancer
- Registration Number
- NL-OMON39514
- Lead Sponsor
- ovartis
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 15
* Women (* 18 years) with histologically confirmed ER-positive and/or PgR-positive and HER2-negative inoperable locally advanced or metastatic breast cancer.
* Known PI3K pathway status (Novartis central lab).
* Postmenopausal (see protocol page 47 for details).
* Refractory to aromatase inhibitors (see protocol page 47 for details).
* (Non) measurable disease as per RECIST 1.1 criteria.
* Patient has adequate bone marrow and organ function
* Fasting plasma glucose * 6.7 mmol/L, HbA1c * 8%.
* ECOG performance status 0-2.
* Previous treatment with a PI3K inhibitor
* More than one chemotherapy line for metastatic disease (see protocol page 48 for details).
* Symptomatic CNS metastases.
* Wide field radiotherapy * 4 weeks or limited field radiation for palliation * 2 weeks prior to starting study drug.
* Chronic treatment (> 5 days) with corticosteroids or another immunosuppressive agent, as chronic administration of corticosteroids (> 5 days) can induce CYP3A4. Exceptions see protocol page 49.
* Coumarin derived anti-coagulant. Therapy with heparin, LMWH, or fondaparinux is allowed
* Drugs known to be moderate or strong inhibitors or inducers of isoenzyme CYP3A.
* Score * 12 on the PHQ-9 questionnaire.
* Response of *1, 2 or 3* to question number 9 on the PHQ-9 questionnaire regarding potential for suicidal thoughts or ideation (independent of the total score of the PHQ-9).
* GAD-7 mood scale score * 15.
* Documented history of or active major depressive episode, bipolar disorder (I or II), obsessive-compulsive disorder, schizophrenia, a history of or current risk of doing harm to self or others.
* * CTCAE grade 3 anxiety.
* Active cardiac disease or a history of cardiac dysfunction. See protocol page 49-50 for details.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Progression free survival.</p><br>
- Secondary Outcome Measures
Name Time Method <p>Overall survival, Overall response rate, Clinical benefit rate, Safety, PK,<br /><br>Quality of life.<br /><br>Time to deterioration ECOG performance</p><br>