Breast CancerPhase 2/3NCT00684216
Second-line Endocrine Treatment Followed by Capecitabine Versus Capecitabine Followed by Endocrine Treatment in Patients With Metastatic ER Positive Breast Cancer
A Phase 2/3 study testing capecitabine and hormonal treatment (tamoxifen, exemestane, anastrozole or letrozole) in people with Breast Cancer, run by The Netherlands Cancer Institute at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- capecitabine and hormonal treatment (tamoxifen, exemestane, anastrozole or letrozole)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteNetherlands
- Study dates
- Apr 2008to May 2013
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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 -
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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).
- Conditions
- Breast Cancer
- Being tested
- capecitabine, hormonal treatment (tamoxifen, exemestane, anastrozole or letrozole)
- Keywords
- metastatic, ER positive, PD during/after first line hormonal treatment
- Medical subject headings
- Breast Neoplasms, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
capecitabineDrug
200 mg, BID, PO, QD until progression of disease
hormonal treatment (tamoxifen, exemestane, anastrozole or letrozole)Drug
either tamoxifen or aromatase inhibitor (exemestane, anastrozole or letrozole), QD, until progression of disease
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | capecitabine followed by hormonal treatment Receives: Drug: capecitabine; Drug: hormonal treatment (tamoxifen, exemestane, anastrozole or letrozole) |
| 2 | Active comparator | hormonal treatment followed by capecitabine Receives: Drug: capecitabine; Drug: hormonal treatment (tamoxifen, exemestane, anastrozole or letrozole) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of life during the study period: Physical functioning scale of the QLQ-C30; Global Health status/QoL of the QLQ-C30
Measured: every 6 weeks
Secondary outcomes (1)
Time to second progression and quality of life adjusted time to 2nd recurrence.
Measured: at the end of the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2008 (estimated)
- Study startApr 2008
- Primary completionMay 2012
- Study completionMay 2013
Why it stopped: acrual too slow
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by The Netherlands Cancer InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Netherlands Cancer Institute
- Sponsor type
- University, hospital or other
- Investigators
- Sjoerd Rodenhuis, MD, Principal investigator, The Netherlands Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00684216
- Sponsor's protocol ID
- N07MAN
- Other IDs
- Eudract 2007-007030-20
- Status last verified
- May 2012
- First submitted
- 22 May 2008
- Last updated
- 14 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00684216
- Acronym / sponsor ID
- N07MAN
- Conditions
- Breast Cancer
- Keywords
- metastatic, ER positive, PD during/after first line hormonal treatment
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: acrual too slow
- Enrolment
- 10 participants (actual)
- Lead sponsor
- The Netherlands Cancer InstituteUniversity, hospital or other
- Study start
- Apr 2008
- Primary completion
- May 2012 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 26 May 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: capecitabine, Drug: hormonal treatment (tamoxifen, exemestane, anastrozole or letrozole)capecitabine followed by hormonal treatment |
| 2 | Active comparator | Drug: capecitabine, Drug: hormonal treatment (tamoxifen, exemestane, anastrozole or letrozole)hormonal treatment followed by capecitabine |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| capecitabine200 mg, BID, PO, QD until progression of disease | Drug | 1, 2 |
| hormonal treatment (tamoxifen, exemestane, anastrozole or letrozole)either tamoxifen or aromatase inhibitor (exemestane, anastrozole or letrozole), QD, until progression of disease | Drug | 1, 2 |
Primary outcome
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
1 secondary outcome
Time to second progression and quality of life adjusted time to 2nd recurrence.
Time frame: at the end of the study
Results and safety
The study was stopped early (reason given: acrual too slow). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sjoerd Rodenhuis, MD principal investigator
The Netherlands Cancer Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing capecitabine and hormonal treatment (tamoxifen, exemestane, anastrozole or letrozole) in people with Breast Cancer, run by The Netherlands Cancer Institute at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 14 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: acrual too slow). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2017.