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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-04-30

Study Completion Date

2013-05-31

Brief Summary

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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.

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Detailed Description

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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).

Conditions

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Breast Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

capecitabine followed by hormonal treatment

Group Type ACTIVE_COMPARATOR

capecitabine

Intervention Type DRUG

200 mg, BID, PO, QD until progression of disease

hormonal treatment (tamoxifen, exemestane, anastrozole or letrozole)

Intervention Type DRUG

either tamoxifen or aromatase inhibitor (exemestane, anastrozole or letrozole), QD, until progression of disease

2

hormonal treatment followed by capecitabine

Group Type ACTIVE_COMPARATOR

capecitabine

Intervention Type DRUG

200 mg, BID, PO, QD until progression of disease

hormonal treatment (tamoxifen, exemestane, anastrozole or letrozole)

Intervention Type DRUG

either tamoxifen or aromatase inhibitor (exemestane, anastrozole or letrozole), QD, until progression of disease

Interventions

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capecitabine

200 mg, BID, PO, QD until progression of disease

Intervention Type DRUG

hormonal treatment (tamoxifen, exemestane, anastrozole or letrozole)

either tamoxifen or aromatase inhibitor (exemestane, anastrozole or letrozole), QD, until progression of disease

Intervention Type DRUG

Eligibility Criteria

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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

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No