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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


Phase 2/Phase 3
N/A
N/A
Not Enrolling
Female
Breast Cancer

Thank you

Trial Information

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


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).


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Quality of life during the study period: Physical functioning scale of the QLQ-C30; Global Health status/QoL of the QLQ-C30

Outcome Time Frame:

every 6 weeks

Safety Issue:

No

Principal Investigator

Sjoerd Rodenhuis, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

NKI-AvL

Authority:

Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Study ID:

N07MAN

NCT ID:

NCT00684216

Start Date:

April 2008

Completion Date:

May 2013

Related Keywords:

  • Breast Cancer
  • metastatic
  • ER positive
  • PD during/after first line hormonal treatment
  • Breast Neoplasms

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