Second-line Endocrine Treatment Followed by Capecitabine Versus Capecitabine Followed by Endocrine Treatment in Patients With Metastatic ER Positive Breast Cancer

• Status: Terminated
• Trial end date: 2013-05-01
• Target enrollment: 0
• Participant gender: Female

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 anticipated that the time on study (which is the time between randomization and the discontinuation of the second treatment in the sequence) will be similar for both arms of the study. The quality of life during this period, however, could be better in the patient group receiving the most effective first agent in the sequence. If this proves to be true, the conventional wisdom that endocrine therapy should be continued until no further endocrine options remain, must be abandoned.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The Netherlands Cancer Institute
• Treatments: Anastrozole; Capecitabine; Exemestane; Letrozole; Tamoxifen

Criteria

Inclusion Criteria:

1. Written informed consent.

2. Proven infiltrating breast cancer with distant metastases or inoperable locally advanced disease.

3. Positive estrogen receptor (≥ 10% positive nuclei at immunohistochemistry). Progesterone and HER-2 neu receptor have to be known.

4. - 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).

5. No prior chemotherapy for metastatic disease

6. Willing and able to participate in Quality of Life investigation -

Exclusion Criteria:

1. 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.

2. Pregnancy or breast feeding women.

3. Contra-indications to the use of capecitabine

4. Known CNS metastases