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

Breast Cancer Clinical Trial

Official title:

Randomized Phase II/III Study of Second-line Endocrine Treatment Followed by Capecitabine Versus Capecitabine Followed by Endocrine Treatment in Patients With Metastatic Estrogen Receptor Positive Breast Cancer

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00684216
• Other study ID #: N07MAN
• Secondary ID: Eudract 2007-007
• Status: Terminated
• Phase: Phase 2/Phase 3
• First received: May 22, 2008
• Last updated: September 13, 2017
• Start date: April 2008
• Est. completion date: May 2013

Study information

• Verified date: May 2012
• Source: The Netherlands Cancer Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 10
• Est. completion date: May 2013
• Est. primary completion date: May 2012
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Drug:
• capecitabine
200 mg, BID, PO, QD until progression of disease
• hormonal treatment (tamoxifen, exemestane, anastrozole or letrozole)
either tamoxifen or aromatase inhibitor (exemestane, anastrozole or letrozole), QD, until progression of disease

Locations

Country	Name	City	State
Netherlands	NKI-AVL	Amsterdam

Sponsors (1)

Lead Sponsor	Collaborator
The Netherlands Cancer Institute

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quality of life during the study period: Physical functioning scale of the QLQ-C30; Global Health status/QoL of the QLQ-C30		every 6 weeks
Secondary	Time to second progression and quality of life adjusted time to 2nd recurrence.		at the end of the study