Status:
TERMINATED
Second-line Endocrine Treatment Followed by Capecitabine Versus Capecitabine Followed by Endocrine Treatment in Patients With Metastatic ER Positive Breast Cancer
Lead Sponsor:
The Netherlands Cancer Institute
Conditions:
Breast Cancer
Eligibility:
FEMALE
Phase:
PHASE2
PHASE3
Brief Summary
This trial studies the effects on quality of life and on time to second progression of the sequence endocrine therapy-capecitabine versus the sequence capecitabine-endocrine treatment. It is anticipat...
Detailed Description
This is a randomized phase II/II study. Patients are randomized for the sequence capecitabine-hormonal therapy versus hormonal therapy- capecitabine. At progression the patient should receive the othe...
Eligibility Criteria
Inclusion
- Written informed consent.
- Proven infiltrating breast cancer with distant metastases or inoperable locally advanced disease.
- Positive estrogen receptor (≥ 10% positive nuclei at immunohistochemistry). Progesterone and HER-2 neu receptor have to be known.
- \- Progressive disease during first line hormonal therapy (either tamoxifen or aromatase inhibitor) for metastatic or inoperable locally advanced disease. Simultaneous use of LH-RH analogs is allowed. OR - Recurrence of disease (M1) during adjuvant hormonal therapy (either tamoxifen or aromatase inhibitor).
- No prior chemotherapy for metastatic disease
- Willing and able to participate in Quality of Life investigation -
Exclusion
- Other malignancy except carcinoma in situ, unless the other malignancy was treated 5 or more years ago with curative intent without the use of chemotherapy or radiation therapy.
- Pregnancy or breast feeding women.
- Contra-indications to the use of capecitabine
- Known CNS metastases
Key Trial Info
Start Date :
April 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2013
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT00684216
Start Date
April 1 2008
End Date
May 1 2013
Last Update
September 14 2017
Active Locations (1)
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1
NKI-AVL
Amsterdam, Netherlands, 1066 CX