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 - Capecitabine vs hormonal treatment

• Conditions: metastatic breast cancer

• Registration Number: EUCTR2007-007030-20-NL
• Lead Sponsor: KI-AV

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-12-11
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Female
• Target Recruitment: Not specified

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.Non-measurable M1 disease is accepted.
6.Performance status: WHO 0 - 2.
7.Adequate bone marrow function (WBC count > 3.0 x 109/l, platelets > 100 x 109/l).
8.Adequate hepatic function (ALAT, ASAT and bilirubine < 2 times the upper limit of normal; in case of liver metastases ALAT and ASAT should be less than 5 times the upper limit of normal).
9.Adequate renal function (serum creatinine< 1.5 upper limit of normal).
10.Willing and able to participate in Quality of Life investigation.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1.Prior chemotherapy for metastatic disease
2.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.
3.Pregnancy or breast feeding must be excluded and patients must use adequate contraceptive protection.
4.Eligibly for any other ongoing clinical trial in the NKI-AVL (this study has ‘posteriority’).
5.Contra-indications to the use of capecitabine (at the discretion of the treating physician)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified