EUCTR2012-002707-18-IT
Active, not recruiting
Not Applicable
EFFECT: A randomized phase II study to evaluate the EFficacy and impact on Function of two different doses of nab-paclitaxEl in elderly patients with advanCed breasT cancer - EFFECT
FONDAZIONE SANDRO PITIGLIANI PER LA LOTTA CONTRO I TUMORI-ONLUS0 sitesOctober 25, 2012
ConditionsPatients aged 65 years or older with histologically or cytologically confirmed breast cancer, locally recurrent and/or metastaticany estrogen/progesterone receptor statusHER2 receptor negative OR HER2 positive but with contraindication to anti-HER2 therapyMedDRA version: 14.1Level: PTClassification code 10055113Term: Breast cancer metastaticSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Patients aged 65 years or older with histologically or cytologically confirmed breast cancer, locally recurrent and/or metastatic
- Sponsor
- FONDAZIONE SANDRO PITIGLIANI PER LA LOTTA CONTRO I TUMORI-ONLUS
- Status
- Active, not recruiting
- Last Updated
- 12 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Histologically or cytologically confirmed breast cancer, locally recurrent and/or metastatic; any estrogen/progesterone receptor status; HER2 receptor negative OR HER2 positive but with contraindication to anti\-HER2 therapy (e.g. known congestive cardiac failure).
- •Measurable disease or non\-measurable but evaluable disease according to RECIST 1\.1 criteria (see Appendix B) \[Eisenhauer]
- •Age \= 65 years
- •ECOG performance status 0\-2
- •Estimated life expectancy of \= 12 weeks
- •oStaging CT or MRI brain is required only if clinically indicated
- •Adequate organ function
- •No significant peripheral neuropathy (significant peripheral neuropathy is defined as \= grade 2 on CTCAE v4\.0 criteria)
- •No clinically significant comorbidities including: uncontrolled cardiac arrhythmias (with the exception of rate\-controlled atrial fibrillation), NYHA class III or IV cardiac failure, uncontrolled diabetes, hypertension or other medical conditions that may interfere with assessment of toxicity
- •No other malignancy within the last 5 years, with the exception of adequately treated non\-melanomatous skin cancers, cervical intraepithelial neoplasia or cervical carcinoma in situ
Exclusion Criteria
- •\- active/symptomatic CNS metastases
- •\- previous chemotherapy for breast cancer in the advanced setting
Outcomes
Primary Outcomes
Not specified
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