Pre-surgical effects of serms, anti-COX-2 and aromatase inhibitors in breast cancer patients

Phase 2

Completed

• Conditions: Estrogen receptor positive breast cancer; Cancer; Malignant neoplasm of breast

• Registration Number: ISRCTN86894592
• Lead Sponsor: European Institute of Oncology [Fondazione Istituto Europeo di Oncologia (FIEO)] (Italy)

Brief Summary

2019 results in: https://www.ncbi.nlm.nih.gov/pubmed/30967597 [added 11/04/2019]

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2009-03-31
• Study Start: 2012-09-11
• Last Update Posted: 5 May 2019

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 125

Inclusion Criteria

1. Female, aged at least 18 years old, no upper age limit
2. Performance status = 0 (SWOG)
3. Histologically-confirmed ER+ primary breast cancer candidated for conservative surgery
4. Stage T1-2, N0-1, M0 or women with larger tumors who refuse chemo and/or endocrine therapy before surgery
5. No previous treatment for breast cancer
6. Provision of written informed consent

Exclusion Criteria

1. Previous treatment for breast cancer including chemotherapy and endocrine therapy
2. Patients eligible to neoadjuvant chemo and/or endocrine therapy
3. Evidence of previous superficial or deep venous thrombosis or other thrombo-embolic events of relevance (pulmonary embolism, stroke, etc)
4. Current anti-coagulant therapy
5. Moderate to severe alteration in hematologic profile, hemostasis, renal and hepatic metabolism
6. Clinically active peptic ulcer or gastroenteric disease
7. Severe retinal disease
8. Severe endometriosis (grade III-IV) or other proliferative disorders of the endometrium
9. Clinically active neurologic or psychiatric disease
10. Other medical contraindications as judged by the investigator
11. Other co-existing malignancies or malignancies diagnosed within the last 5 years with the exception of basal cell carcinoma or cervical cancer in situ
12. Pregnancy or current breast feeding (women of child-bearing potential must have a negative pregnancy test within 7 days before the start of study treatment)

Study & Design

• Study Type: Interventional
• Study Design: Not specified