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

Netherlands Cancer Institute (NKI)

Status and phase: Terminated; Phase 3; Phase 2

Conditions: Breast Cancer

Treatments: Drug: capecitabine; Drug: hormonal treatment (tamoxifen, exemestane, anastrozole or letrozole)

Study type: Interventional

Funder types: Other

Identifiers

NCT00684216

N07MAN

Eudract 2007-007030-20

Details and patient eligibility

About

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.

Full 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).

Enrollment: 10 patients

Sex: Female

Volunteers: No Healthy Volunteers

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 design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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10 participants in 2 patient groups

1

Active Comparator group

Description:

capecitabine followed by hormonal treatment

Treatment:

Drug: hormonal treatment (tamoxifen, exemestane, anastrozole or letrozole)

Drug: capecitabine

2

Active Comparator group

Description:

hormonal treatment followed by capecitabine

Treatment:

Drug: hormonal treatment (tamoxifen, exemestane, anastrozole or letrozole)

Drug: capecitabine