Everolimus trIal for Advanced prememopausaL Breast Cancer Patients

• Status: Unknown status
• Trial end date: 2017-12-01
• Target enrollment: 0
• Participant gender: Female

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, the superiority of addition of everolimus to endocrine therapy hasn't been established in the premenopausal women. This is a phase 2, multicentre clinical trial to evaluate the role of everolimus in the first-line endocrine treatment of premenopausal MBC patients after progression on tamoxifen.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Chinese Academy of Medical Sciences
• Collaborator: Novartis Pharmaceuticals
• Treatments: Everolimus; Goserelin; Letrozole; Sirolimus

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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.