Status:
COMPLETED
Red Clover and Lifestyle Changes to Contrast Menopausal Symptoms in Premenopausal Breast Cancer Patients Given Tamoxifen
Lead Sponsor:
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Conditions:
Breast Cancer
Eligibility:
FEMALE
18-60 years
Phase:
PHASE2
Brief Summary
A prospective double-blind randomized trial of red clover extract (Promensil) vs placebo in surgically-treated premenopausal women with estrogen receptor-positive breast cancer taking tamoxifen
Detailed Description
Premenopausal women with ER-positive breast cancer treated by surgery and receiving postoperative tamoxifen with or without LHRH analogues, who may have received pre or postoperative chemotherapy, or ...
Eligibility Criteria
Inclusion
- Histologically confirmed operable ER-positive breast cancer
- Can be ductal carcinoma in situ (DCIS)
- Absence of locoregional relapse or distant metastasis
- Normal ovarian function
- Menopause Rating Score \> or equal to 8
- Signed informed consent to participate
Exclusion
- Menopause Rating Score \<8
- Menopausal at diagnosis or at surgery
- Previous malignancies other than in situ cervical carcinoma or non-melanoma skin cancer
- Breast cancer recurrence
- Metastatic breast cancer
- Non-epithelial breast cancer at histological examination
- In situ lobular breast cancer
- Participation in other randomized clinical trials that could interfere with current study
- Living distant from center and unable to attend for check-ups and meetings.
Key Trial Info
Start Date :
July 5 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 23 2016
Estimated Enrollment :
88 Patients enrolled
Trial Details
Trial ID
NCT03844685
Start Date
July 5 2012
End Date
February 23 2016
Last Update
February 20 2019
Active Locations (1)
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1
Cristina Ferraris
Milan, Italy, 20133