eoadjuvant study of Chemotherapy versus EndocriNe Therapy in postmenopausal patients with primary breast cancer

Phase 3

Completed

• Conditions: Breast Cancer; Cancer; Breast cancer

• Registration Number: ISRCTN77234840
• Lead Sponsor: Imperial College London (UK)

Brief Summary

2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/25395314

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2006-07-13
• Study Completion: 2011-03-31
• Last Update Posted: 6 April 2020

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 716

Inclusion Criteria

1. Histologically proven primary breast cancer which is thought to require mastectomy and where it is felt that cytoreductive systemic therapy would enable conservative surgery to be performed.
2. Postmenopausal up to the age of 75 years of age
3. Estrogen-receptor positive
4. Pre-treatment haematology and biochemistry values within acceptable limits
5. World Health Organisation (WHO) performance status zero or one
6. Primary breast tumour amenable to biopsy
7. Consent to having a repeat biopsy of breast tumour
8. Written informed consent prior to commencement of specific protocol procedures

Exclusion Criteria

1. Indicated for urgent neoadjuvant therapy, i.e., inflammatory or near ulcerating breast cancer
2. Bilateral invasive breast cancer
3. Any prior chemotherapy, hormone therapy or radiation for breast cancer
4. Evidence of distant metastatic disease as disclosed by bone scan, liver ultrasound scan and chest radiology
5. Past or current history of neoplasm other than breast carcinoma, except for:
a. curatively treated non-melanoma skin cancer
b. in situ carcinoma of the cervix
c. other cancer curatively treated and with no evidence of disease for at least ten years
d. ipsilateral Ductal Carcinoma In-Situ (DCIS) of the breast
e. Lobular Carcinoma In-Situ (LCIS) of the breast
6. Other serious illness or medical condition:
a. congestive heart failure or unstable angina pectoris, previous history of myocardial infarction within one year from study entry, uncontrolled hypertension or high-risk uncontrolled arrhythmias
b. history of significant neurologic or psychiatric disorders including psychotic disorders, dementia or seizures that would prohibit the understanding and giving of informed consent
c. active uncontrolled infection
d. active peptic ulcer, unstable diabetes mellitus
7. In the opinion of the investigator, any evidence of severe or uncontrolled systemic disease such as unstable hypertension, respiratory, cardiac, hepatic, and renal disease

Study & Design

• Study Type: Interventional
• Study Design: Not specified