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

Primary Purpose

Breast Cancer

Status
Terminated
Phase
Phase 2
Locations
Netherlands
Study Type
Interventional
Intervention
capecitabine
hormonal treatment (tamoxifen, exemestane, anastrozole or letrozole)
Sponsored by
The Netherlands Cancer Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breast Cancer focused on measuring metastatic, ER positive, PD during/after first line hormonal treatment

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • NKI-AVL

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

1

2

Arm Description

capecitabine followed by hormonal treatment

hormonal treatment followed by capecitabine

Outcomes

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

Secondary Outcome Measures

Time to second progression and quality of life adjusted time to 2nd recurrence.

Full Information

First Posted
May 22, 2008
Last Updated
September 13, 2017
Sponsor
The Netherlands Cancer Institute
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1. Study Identification

Unique Protocol Identification Number
NCT00684216
Brief Title
Second-line Endocrine Treatment Followed by Capecitabine Versus Capecitabine Followed by Endocrine Treatment in Patients With Metastatic ER Positive Breast Cancer
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2012
Overall Recruitment Status
Terminated
Why Stopped
acrual too slow
Study Start Date
April 2008 (undefined)
Primary Completion Date
May 2012 (Actual)
Study Completion Date
May 2013 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
The Netherlands Cancer Institute

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
metastatic, ER positive, PD during/after first line hormonal treatment

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
capecitabine followed by hormonal treatment
Arm Title
2
Arm Type
Active Comparator
Arm Description
hormonal treatment followed by capecitabine
Intervention Type
Drug
Intervention Name(s)
capecitabine
Intervention Description
200 mg, BID, PO, QD until progression of disease
Intervention Type
Drug
Intervention Name(s)
hormonal treatment (tamoxifen, exemestane, anastrozole or letrozole)
Intervention Description
either tamoxifen or aromatase inhibitor (exemestane, anastrozole or letrozole), QD, until progression of disease
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
Time to second progression and quality of life adjusted time to 2nd recurrence.
Time Frame
at the end of the study

10. Eligibility

Sex
Female
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Written informed consent. Proven infiltrating breast cancer with distant metastases or inoperable locally advanced disease. Positive estrogen receptor (≥ 10% positive nuclei at immunohistochemistry). Progesterone and HER-2 neu receptor have to be known. - 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). No prior chemotherapy for metastatic disease Willing and able to participate in Quality of Life investigation - Exclusion Criteria: 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. Pregnancy or breast feeding women. Contra-indications to the use of capecitabine Known CNS metastases
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sjoerd Rodenhuis, MD
Organizational Affiliation
NKI-AvL
Official's Role
Principal Investigator
Facility Information:
Facility Name
NKI-AVL
City
Amsterdam
ZIP/Postal Code
1066 CX
Country
Netherlands

12. IPD Sharing Statement

Learn more about this trial

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

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