Clinical Trial to study the effect of the treatment with eribulin and endocrine therapy in metastatic breast cancer patients
- Conditions
- uminal Metastatic Breast CancerTherapeutic area: Diseases [C] - Cancer [C04]MedDRA version: 20.0 Level: LLT Classification code 10027475 Term: Metastatic breast cancer System Organ Class: 100000004864MedDRA version: 20.1 Level: LLT Classification code 10070575 Term: Estrogen receptor positive breast cancer System Organ Class: 100000004864
- Registration Number
- EUCTR2017-004324-30-ES
- Lead Sponsor
- Medica Scientia Innovation Research (MEDSIR)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- Not specified
- Target Recruitment
- 60
Patients are eligible for inclusion only if they meet ALL of the following criteria:
1. Patients have been informed about the nature of study, and have agreed to participate in the study, and signed the informed consent approved by the institution’s independent ethical committee/institutional review board.
2. Female patients over 18 years of age.
3. Patients with a histologically confirmed diagnosis of ER-positive and/or PR-positive breast cancer by local laboratory.
4. Patients with HER2-negative breast cancer through in situ hybridization test (fluorescence in situ hybridization [FISH], chromogenic in situ hybridization [CISH], or silver enhanced in situ hybridization [SISH]) or negative immunohistochemical status of 0 or 1+. If IHC is 2+, a negative in situ hybridization (FISH, CISH, or SISH) test is required by local laboratory testing.
5. Unresectable locally advanced or metastatic breast cancer.
6. Confirmed disease progression while in the last aromatase inhibition- containing regimen in the metastatic setting (Note: not necessarily in the treatment line immediately prior to study entry) or within 6 months from last AI dose in the adjuvant setting. Treatment with prior CDK4/6 or mTOR inhibitor therapy is allowed.
7. At least one taxane or anthracycline regimen in either the adjuvant or the neoadjuvant setting.
8. Patients with no prior line of chemotherapy in the metastatic setting.
9. At least 1 and up to 3 prior lines of endocrine therapy in the metastatic setting (except for patients progressing during the adjuvant setting or before 6 months after completing adjuvant endocrine therapy).
10. Eastern Cooperative Oncology Group (ECOG) score 0 or 1.
11. Patients have adequate bone marrow and organ function as defined by the following laboratory values:
-Absolute neutrophil count (ANC) = 1.5 x 109 /L.
-Platelets = 100 x 109 /L.
-Hemoglobin = 9 g/dL.
-Sodium, potassium, calcium (corrected for serum albumin), and magnesium within normal limits for the institution.
-Adequate renal function as evidenced by calculated creatinine clearance =50 mL/min per the Cockcroft and Gault formula: Cr.Cl.= 0.85 * ((140 – Age years) / (SerumCreat mg/dL)) * (Weight Kg / 72).
-Adequate liver function as evidenced by bilirubin =1.5 times the upper limit of normal (ULN), alanine aminotransferase (ALT), and aspartate aminotransferase (AST) =3×ULN (in the case of liver metastases =5×ULN).
12. Patients must have measurable disease (according to RECIST criteria v.1.1).
13. Premenopausal and postmenopausal women. Premenopausal women must be treated, with LHRH analogues for at least 28 days (if shorter LHRH treatment period, post-menopausal estrogen levels must be confirmed on laboratory assessments) prior to study entry. Premenopausal or postmenopausal status should have been established before starting the previous treatment with an AI +/- LHRH analogue based on the following classification:
• Postmenopausal status is defined as either:
a) Prior bilateral oophorectomy
or
b) Age > 60 years
or
c) Age < 60 years and amenorrheic for 12 months in the abs
Patients will be excluded from the study if they meet ANY of the following criteria:
1. Have received radiation therapy or limited-field palliative radiotherapy within two weeks prior to Cycle 1, Day 1, or patients who have not recovered from radiotherapy-related toxicities to baseline or grade £ 1 (except alopecia) and/or from whom =25% of the bone marrow has been previously irradiated.
2. Have received prior chemotherapy for locally advanced or metastatic disease.
3. Have peripheral neuropathy grade 2 or greater.
4. QTc >480 msec on basal assessments, history of congenital or personal history of long QT syndrome, Brugada syndrome, or Torsade de Pointes (TdP), or uncontrolled electrolyte disorders
5. Child-bearing potential women not using highly effective methods of contraception (contraception should continue during dosing and up to 90 days after study drugs discontinuation).
6. Known hypersensitivity to eribulin, endocrine therapy or its excipients.
7. Other malignancies within the previous two years except adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of cervix or breast.
8. Known uncontrolled metastases to the central nervous system (CNS) or any progressing CNS disease. (Note: Known brain metastases are considered active, if brain imaging during screening demonstrates progression of existing metastases and/or appearance of new lesions compared to brain imaging performed at least four weeks earlier and/or neurological symptoms attributed to brain metastases have not returned to baseline and/or steroids were used for brain metastases within 28 days of randomization)
9. Have a serious concomitant systemic disorder (e.g. active infection including HIV, or cardiac disease) incompatible with the study (at the discretion of investigator)
10. Major surgical procedure (defined as requiring general anaesthesia) or significant traumatic injury within 28 days prior to randomization, or patients who have not recovered from the side effects of any major surgery, or patients that may require major surgery during the course of the study.
11. Have received any anti-cancer biology or investigational treatment within 30 days prior to randomization.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method