PalbocIclib in PreMenopausal Women With ER Positive/HER-2 Negative MetAstatic Breast Cancer (FATIMA)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02917005|
Recruitment Status : Recruiting
First Posted : September 28, 2016
Last Update Posted : August 28, 2019
This is an open label, randomized, multicenter, international phase II study for premenopausal patients with hormone receptor positive, HER2 negative metastatic or locally advanced breast cancer. Patients will be randomized to receive either palbociclib + exemestane + OFS (Arm 1) or exemestane +OFS (Arm 2).
Treatment will be continued until disease progression, unacceptable toxicities, or withdrawal of consent.
|Condition or disease||Intervention/treatment||Phase|
|Metastatic Breast Cancer||Drug: Palbociclib Drug: Exemestane Drug: Goserelin||Phase 2|
There is a strong in-vitro and clinical evidence suggesting that the dual inhibition of CDK 4/6 and ER signaling is a highly effective therapeutic strategy in HR+ MBC. With the unprecedented success of palbociclib in PALOMA-1 trial, several phase 2 and 3 trials are underway to evaluate this agent (and other CDK4/6 inhibitors as well) in the different clinical scenarios of HR+ breast cancer .The vast majority of these trials -if not all- are testing these novel agents in postmenopausal patients, which would render the clinical experience of these agents restricted to postmenopausal women (median age was 62 years in PALOMA-1 trial) The scarcity of clinical trials addressing endocrinal therapy in premenopausal women with MBC is, at least in part, related to the fact that the majority of women in western countries are diagnosed with breast cancer during their postmenopausal life. However the situation is rather different in many countries, including those in the Middle East region, where the median age of women diagnosed with breast cancer is below 50 years, and where approximately 50% of these patients are still menstruating.
This study will be the first to explore the therapeutic effects of palbociclib when combined with exemestane and ovarian function suppression (OFS) in premenopausal with hormone receptor positive and HER2 negative MBC, and how it will compare to the classic approach of using OFS plus an aromatase inhibitor.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||160 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Study of Ovarian Function Suppression And ExemesTane With or Without PalbocIclib in PreMenopausal Women With ER Positive / HER-2 Negative MetAstatic Breast Cancer|
|Actual Study Start Date :||May 7, 2019|
|Estimated Primary Completion Date :||November 2021|
|Estimated Study Completion Date :||December 2023|
Experimental: Palbociclib Arm
Palbociclib (Pfizer) 125mg/day orally for 3 weeks followed by 1 week off plus Exemestane (Pfizer) 25mg/day orally continuously plus Goserelin (Astrazeneca) 3.6 mg SC given every 28 days
CDK 4/6 inhibitor
Other Name: Ibrance
Other Name: Aromasine
Other Name: Zoladex
Active Comparator: Control Arm
Exemestane (Pfizer) 25mg/day orally continuously plus Goserelin (Astrazeneca) 3.6 mg SC given every 28 days
Other Name: Aromasine
Other Name: Zoladex
- Progression free survival [ Time Frame: 28 months ]
- Overall response rate [ Time Frame: 28 months ]
- Clinical benefit rate [ Time Frame: 28 months ]
- Overall survival [ Time Frame: 52 months ]
- Incidence of treatment related adverse events [ Time Frame: 28 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02917005
|Contact: Loay M. Kassem, MD||01003022907||Loay.email@example.com|
|Wits Oncology center||Recruiting|
|Johannesburg, South Africa, 2050|
|Contact: Georgia Demetriou, M.D firstname.lastname@example.org|