Status:
UNKNOWN
Everolimus trIal for Advanced prememopausaL Breast Cancer Patients
Lead Sponsor:
Chinese Academy of Medical Sciences
Collaborating Sponsors:
Novartis Pharmaceuticals
Conditions:
Metastatic Breast Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
Brief Summary
Everolimus has been approved to be effective when used with exemestane after progression on non-steroidal aromatase inhibitors in postmenopausal women based on the BOLERO-2 clinical trial. However, th...
Detailed Description
Endocrine therapy is the cornerstone of treatment for patients with hormone receptor (HR)-positive advanced breast cancer. The selection of endocrine agents takes account of the menopausal status, the...
Eligibility Criteria
Inclusion
- Adult women (≥ 18 years of age) with metastatic or locally advanced breast cancer not amenable to curative surgery.
- Histological confirmation of estrogen and/or progesterone-receptor positive (ER+), human epidermal growth factor receptor 2 negative (HER2 -) breast cancer.
- ER/PR positive: nuclear reaction \> 1%, HER2 negative: HER2; IHC 0,1+ or FISH/CISH (-) in case of IHC 2+
- Patients who:
- received Tamoxifen for at least 6 months during adjuvant treatment and recurred during or within 24 months after the end of adjuvant treatment completion,
- progressed during tamoxifen treatment for advanced disease.
- Pre-menopausal status was defined as either :
- The patient has a history of regular menstrual periods within 12 weeks prior to study enrollment
- The patient has FSH and E2 levels with in pre-menopausal range based on local laboratory assessments measured (i.e, FSH ≤ 40 mIU/mL and E2 ≥10 pg/mL)within 12 weeks prior to study enrollment.
- ECOG performance status of 0,1, or 2
- At least one measurable lesion or mainly lytic bone lesions in the absence of measurable disease(RECIST1.1)
- Adequate bone marrow, hepatic, and renal function
- Adequate bone marrow and coagulation function as shown by:
- Absolute neutrophil count (ANC) ≥ 1.5 109/L;Platelets\>100 x109/L;Hemoglobin (Hgb) \> 9.0g/dLINR \< 2
- Adequate liver function as shown by:
- Serum aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \< 2.5x ULN (or \<5 if hepatic metastases are present)
- Total serum bilirubin \< 1.5 x ULN (\<3 x ULN for patients known to have Gilberts Syndrome)
- Adequate renal function as shown by:
- Serum creatinine\< 1.5 x ULN
- Fasting serum cholesterol \<300 mg/dL or 7.75 mmol/L and fasting triglycerides \<2.5 x ULN. In case one or both of these thresholds are exceeded, the patient can only be included after initiation of statin therapy and when the above mentioned values have been achieved.
- Written informed consent
Exclusion
- Patients who have received endocrine treatment other than Tamoxifen for adjuvant or metastatic/locally advanced breast cancer.
- Patients who have received goserelin at adjuvant setting
- Patients who received more than one line of chemotherapy for metastatic or locally advanced breast cancer
- Previous treatment with mTOR inhibitors.
- Another malignancy within 5 years prior to enrollment with the exception of adequately treated in-situ carcinoma of the cervix, uteri, basal or squamous cell carcinoma or non-melanomatous skin cancer.
- Symptomatic brain or other CNS metastases
- Patients receiving chronic treatment with immunosuppressive agents.
- Any severe and/or uncontrolled medical conditions, eg. currently active infection
- Pregnant or lactating
- Patients unwilling to or unable to comply with the protocol.
Key Trial Info
Start Date :
December 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2017
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT02313051
Start Date
December 1 2014
End Date
December 1 2017
Last Update
December 9 2014
Active Locations (1)
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1
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Beijing, China, 100021