RANDOMIZED PHASE II/III STUDY OF SECOND-LINE ENDOCRINE TREATMENT FOLLOWED BY CAPECITABINE VERSUS CAPECITABINE FOLLOWED BY ENDOCRINE TREATMENT IN PATIENTS WITH METASTATIC ER POSITIVE BREAST CANCER

Phase 2

Completed

• Conditions: mammary neoplasms; 10006291; breast cancer

• Registration Number: NL-OMON31795
• Lead Sponsor: ederlands Kanker Instituut

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 13 May 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 128

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). Progesteron 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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary endpoints :<br /><br>Quality of life during the study period<br /><br>- Physical functioning scale of the QLQ-C30<br /><br>- Global Health status/QoL of the QLQ-C30</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary endpoint:<br /><br>The EQ-5D Health State Summary Score<br /><br>The EQ-5D VAS Score<br /><br>Time to second progression and quality of life adjusted time<br /><br>to 2nd recurrence.<br /><br>Time to progression after first intervention.<br /><br>Overall survival</p><br>