Status:
UNKNOWN
Capecitabine in Combination With Aromatase Inhibitor Versus Aromatase Inhibitors, in Hormonal Receptor Positive Recurrent or Metastatic Breast Cancer Patients, Randomized Controlled Study
Lead Sponsor:
Ain Shams University
Conditions:
Metastatic Breast Cancer
Eligibility:
FEMALE
Phase:
PHASE2
Brief Summary
Women with recurrent or metastatic breast cancer who are hormone receptor positive are candidates for first line hormonal therapy including aromatase inhibitors. In the past few years new combination ...
Detailed Description
Breast cancer is the most commonly diagnosed cancer and the leading cause of cancer death among women worldwide, accounting for 25% of total cancer cases (Globocan, 2012) It ranks as the most prevalen...
Eligibility Criteria
Inclusion
- Adult women with locoregionally recurrent or metastatic disease not amenable to curative therapy
- Eastern Cooperative Oncology Group (ECOG) 0-2
- Hormone receptor positive
- No prior systemic anti-cancer therapy for advanced ER+ disease ( hormonal therapy)
- Measurable disease defined by revised RECIST criteria (version 1.1), or bone-only disease
- normal laboratory values
- Postmenopausal or premenopausal with oophorectomy (medical or surgical).
Exclusion
- Patients with advanced, symptomatic, visceral spread that are at risk of life threatening complication in the short term
- Prior (neo) adjuvant treatment with same aromatase inhibitor type with DFI =\< 12 months from completion of treatment.
- Known uncontrolled or symptomatic central nervous system metastases
- Second primary malignancy
- Serious uncontrolled intercurrent infections or intercurrent medical or psychiatric illness
- unable to swallow tablets, or malabsorption patients.
- unwilling or unable to comply with study protocol or unable to meet the follow up.
- patients who researchers considered were not suitable to participate.
Key Trial Info
Start Date :
August 30 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2021
Estimated Enrollment :
124 Patients enrolled
Trial Details
Trial ID
NCT04012918
Start Date
August 30 2018
End Date
February 1 2021
Last Update
July 9 2019
Active Locations (1)
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1
Clinical oncology department, Faculty of medicine, Ain Shams University
Cairo, Egypt, 11817