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…
ID
Source
Brief title
Condition
- Breast neoplasms malignant and unspecified (incl nipple)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary endpoints :
Quality of life during the study period
- Physical functioning scale of the QLQ-C30
- Global Health status/QoL of the QLQ-C30
Secondary outcome
Secondary endpoint:
The EQ-5D Health State Summary Score
The EQ-5D VAS Score
Time to second progression and quality of life adjusted time
to 2nd recurrence.
Time to progression after first intervention.
Overall survival
Background summary
It is commonly accepted that the treatment of patients with metastatic disease
which is hormone receptor positive, should be as long as possible with a
treatment with endocrine agents, deferring toxic chemotherapy to a later point
in time. As a result, many patients with ER-positive disease receive subsequent
lines of hormonal agents.
Several chemotherapeutic agents that have significant single agent activity
have become available that are associated with relatively little toxicity. One
of these is capecitabine, an antimetabolite that can be viewed as a
fluorouracil prodrug. Capecitabine can be taken orally and has acceptable
toxicity.
Earlier use of capecitabine in this group of patients may be more favourable.
Study objective
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.
Study design
This is a randomized phase II/II studie. Patients are randomized for the
sequence capecitabine-hormonal therapie 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).
Intervention
Assigned protocol treatment is to be continued until progression (either
clinical or documented by radiology). 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).
At progression of disease after the second treatment the patient will be taken
off study
Patients will be seen on the out patient clinic every 6 weeks.
During the treatment patients will be asked to complete two quality of life
forms every six weeks. Also at start of the second protocol treatment patient
will be asked to complete the quality of life forms.
Therapy is given according to the hospital standard.
Study burden and risks
During treatment patients will be seen on the out patient clinic every 6 weeks.
At this visit hematology and chemistry laboratory tests will be performed.
During the treatment patients will be asked to complete two quality of life
forms every six weeks. Also at start of the second protocol treatment patient
will be asked to complete the quality of life forms
Plesmanlaan 121
1066 CX Amsterdam
NL
Plesmanlaan 121
1066 CX Amsterdam
NL
Listed location countries
Age
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
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2007-007030-20-NL |
| CCMO | NL20922.031.07 |