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

This study has been terminated.
(acrual too slow)
Sponsor:
Information provided by:
The Netherlands Cancer Institute
ClinicalTrials.gov Identifier:
NCT00684216
First received: May 22, 2008
Last updated: May 10, 2012
Last verified: May 2012
  Purpose

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.


Condition Intervention Phase
Breast Cancer
Drug: capecitabine
Drug: hormonal treatment (tamoxifen, exemestane, anastrozole or letrozole)
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by The Netherlands Cancer Institute:

Primary Outcome Measures:
  • Quality of life during the study period: Physical functioning scale of the QLQ-C30; Global Health status/QoL of the QLQ-C30 [ Time Frame: every 6 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time to second progression and quality of life adjusted time to 2nd recurrence. [ Time Frame: at the end of the study ] [ Designated as safety issue: No ]

Enrollment: 10
Study Start Date: April 2008
Estimated Study Completion Date: May 2013
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
capecitabine followed by hormonal treatment
Drug: capecitabine
200 mg, BID, PO, QD until progression of disease
Drug: hormonal treatment (tamoxifen, exemestane, anastrozole or letrozole)
either tamoxifen or aromatase inhibitor (exemestane, anastrozole or letrozole), QD, until progression of disease
Active Comparator: 2
hormonal treatment followed by capecitabine
Drug: capecitabine
200 mg, BID, PO, QD until progression of disease
Drug: hormonal treatment (tamoxifen, exemestane, anastrozole or letrozole)
either tamoxifen or aromatase inhibitor (exemestane, anastrozole or letrozole), QD, until progression of disease

Detailed 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).

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00684216

Locations
Netherlands
NKI-AVL
Amsterdam, Netherlands, 1066 CX
Sponsors and Collaborators
The Netherlands Cancer Institute
Investigators
Principal Investigator: Sjoerd Rodenhuis, MD NKI-AvL
  More Information

No publications provided

Responsible Party: S. Rodenhuis, MD, NKI-AVL
ClinicalTrials.gov Identifier: NCT00684216     History of Changes
Other Study ID Numbers: N07MAN, Eudract 2007-007030-20
Study First Received: May 22, 2008
Last Updated: May 10, 2012
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by The Netherlands Cancer Institute:
metastatic
ER positive
PD during/after first line hormonal treatment

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Capecitabine
Fluorouracil
Letrozole
Anastrozole
Exemestane
Tamoxifen
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Aromatase Inhibitors
Enzyme Inhibitors
Estrogen Antagonists
Estrogen Receptor Modulators
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Selective Estrogen Receptor Modulators
Bone Density Conservation Agents

ClinicalTrials.gov processed this record on September 18, 2014