Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase III, Phase II Treatment Active not specified Other N07MAN Eudract 2007-007030-20, NCT00684216

Trial Description

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.

Further Study Information

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 other protocol treatment (e.g. if the patient was randomized to capecitabine, at progression the treatment should be switched to hormonal treatment).

Eligibility 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

Trial Contact Information

Trial Lead Organizations/Sponsors

Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital

Sjoerd Rodenhuis, MD

Principal Investigator

Sjoerd Rodenhuis, MD
		Email: s.rodenhuis@nki.nl

Ingrid Mandjes, MSc
		Email: i.mandjes@nki.nl

Netherlands
	Amsterdam
	Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital
		Sjoerd Rodenhuis, MD
			Email: s.rodenhuis@nki.nl
		Ingrid Mandjes, MSc
			Email: i.mandjes@nki.nl
		Sjoerd Rodenhuis, MD	Principal Investigator

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00684216
Information obtained from ClinicalTrials.gov on July 16, 2008