Breast CancerPhase 3BREAST-10NCT00540800
BREAST-10: Three-weekly Versus Weekly First-line Chemotherapy for Metastatic or Locally Advanced Breast Cancer
A Phase 3 study testing docetaxel, epirubicin and capecitabine in people with Breast Cancer, run by National Cancer Institute, Naples at 3 sites in Italy.
Trial summary
Some chemotherapies, including docetaxel, are better tolerated and just as effective when giving the dose weekly rather than on an every three week basis. The purpose of this study is to compare 2 schedules of combination chemotherapy with docetaxel for the effects on quality of life. Read more about this study
- Who is it for?
- Ages Up to 70 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- docetaxel, epirubicin and capecitabine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 139 participants
- Where
- 3 sitesItaly
- Study dates
- Feb 2004to Dec 2009
- Phase
- Phase 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 Up to 70 years
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Histological diagnosis of breast cancer
- Inoperable locally advanced or metastatic disease not yet treated with first-line chemotherapy
- Age < 70 years
- ECOG performance status < 2
- Written informed consent
Who cannot join
- Previous or concomitant malignant neoplasm (excluding adequately treated baso or spinocellular skin carcinoma or carcinoma in situ of the cervix)
- Previous treatment with docetaxel
- Symptomatic brain metastases
- Neutrophil < 2000/mm3, platelets < 100,000/mm3, haemoglobin < 10 g/dl
- Creatinine > 1.25 x the upper normal limits
- GOT and/or GPT > 1.25 x the upper normal limits in absence of hepatic metastases
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- GOT and/or GPT > 2.5 x the upper normal limits in presence of hepatic metastases
- Bilirubin > 1.5 x the upper normal limit
- Any concomitant pathology that would, in the investigator's opinion, contraindicate the use of the drugs in this study
- Inability to provide informed consent
- Inability to comply with follow-up
Trial locations and contacts
3 sites in 1 country.
Italy3 sites
Istituto Nazionale dei Tumori , Divisione di Oncologia Medica B
Naples, 80131
Istituto Nazionale dei Tumori, Divisione di Oncologia Medica C
Naples, 80131
Ospedale S. Luca ASL SA 3
Vallo della Lucania
About this study
Official title: Phase III Multicenter Study of the Effects on Quality of Life of Three-weekly Versus Weekly First-line Chemotherapy for Metastatic or Locally Advanced Breast Cancer
Some chemotherapies, including docetaxel, are better tolerated and just as effective when giving the dose weekly rather than on an every three week basis. The purpose of this study is to compare 2 schedules of combination chemotherapy with docetaxel for the effects on quality of life. Standard every three week chemotherapy will be compared with weekly chemotherapy for metastatic or locally advanced breast cancer.
Read the detailed description
Patients with locally advanced breast cancer and patients with metastatic breast cancer who have not previously received an anthracycline will be treated with docetaxel and epirubicin.
Patients with metastatic breast cancer who have already received anthracyclines will be treated with docetaxel and capecitabine.
All patients will be randomized to receive their treatment either on an every three week schedule, or on a weekly schedule.
- Conditions
- Breast Cancer
- Being tested
- docetaxel, epirubicin, capecitabine
- Keywords
- anthracycline pre-treated, chemotherapy, first-line, metastatic breast cancer, locally advanced breast cancer
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
docetaxelDrug
given in combination with epirubicin or capecitabine
epirubicinDrug
for patients with locally advanced breast cancer, or metastatic breast cancer not previously treated with anthracyclines
capecitabineDrug
for metastatic breast cancer patients previously treated with anthracyclines
| Study group | Role | What they receive |
|---|---|---|
| A | Active comparator | Three-weekly chemotherapy Receives: Drug: docetaxel; Drug: epirubicin; Drug: capecitabine |
| B | Experimental | Weekly chemotherapy Receives: Drug: docetaxel; Drug: epirubicin; Drug: capecitabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
quality of life
Measured: during first 6 weeks of chemotherapy
Secondary outcomes (3)
Response rate
Measured: After 12 and 24 weeks of chemotherapy
Toxicity
Measured: every 3 weeks
overall survival
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2007 (estimated)
- Study startFeb 2004
- Primary completionSep 2009
- Study completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 139 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute, Naples
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Andrea de Matteis, M.D., Principal investigator, NCI Naples, Division of Medical Oncology CFrancesco Perrone, M.D., Ph.D., Principal investigator, NCI Naples, Clinical Trials Office
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00540800
- Sponsor's protocol ID
- BREAST-10
- Acronym
- BREAST-10
- Status last verified
- Jan 2016
- First submitted
- 5 Oct 2007
- Last updated
- 14 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Nuzzo F, Morabito A, Gravina A, Di Rella F, Landi G, Pacilio C, Labonia V, Rossi E, De Maio E, Piccirillo MC, D'Aiuto G, Thomas R, Rinaldo M, Botti G, Di Bonito M, Di Maio M, Gallo C, Perrone F, de Matteis A. Effects on quality of life of weekly docetaxel-based chemotherapy in patients with locally advanced or metastatic breast cancer: results of a single-centre randomized phase 3 trial. BMC Cancer. 2011 Feb 16;11:75. doi: 10.1186/1471-2407-11-75.
PubMed 21324184
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase III Multicenter Study of the Effects on Quality of Life of Three-weekly Versus Weekly First-line Chemotherapy for Metastatic or Locally Advanced Breast Cancer
- ClinicalTrials.gov ID
- NCT00540800
- Acronym / sponsor ID
- BREAST-10 / BREAST-10
- Conditions
- Breast Cancer
- Keywords
- anthracycline pre-treated, chemotherapy, first-line, metastatic breast cancer, locally advanced breast cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 139 participants (actual)
- Lead sponsor
- National Cancer Institute, NaplesUniversity, hospital or other
- Study start
- Feb 2004
- Primary completion
- Sep 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 8 Oct 2007 (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.
Some chemotherapies, including docetaxel, are better tolerated and just as effective when giving the dose weekly rather than on an every three week basis. The purpose of this study is to compare 2 schedules of combination chemotherapy with docetaxel for the effects on quality of life. Standard every three week chemotherapy will be compared with weekly chemotherapy for metastatic or locally advanced breast cancer.
Detailed description
Patients with locally advanced breast cancer and patients with metastatic breast cancer who have not previously received an anthracycline will be treated with docetaxel and epirubicin.
Patients with metastatic breast cancer who have already received anthracyclines will be treated with docetaxel and capecitabine.
All patients will be randomized to receive their treatment either on an every three week schedule, or on a weekly schedule.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Active comparator | Drug: docetaxel, Drug: epirubicin, Drug: capecitabineThree-weekly chemotherapy |
| B | Experimental | Drug: docetaxel, Drug: epirubicin, Drug: capecitabineWeekly chemotherapy |
Who may qualify
- Ages
- Up to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Histological diagnosis of breast cancer
- Inoperable locally advanced or metastatic disease not yet treated with first-line chemotherapy
- Age < 70 years
- ECOG performance status < 2
- Written informed consent
Key exclusion criteria (11 listed)
- Previous or concomitant malignant neoplasm (excluding adequately treated baso or spinocellular skin carcinoma or carcinoma in situ of the cervix)
- Previous treatment with docetaxel
- Symptomatic brain metastases
- Neutrophil < 2000/mm3, platelets < 100,000/mm3, haemoglobin < 10 g/dl
- Creatinine > 1.25 x the upper normal limits
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 |
|---|---|---|
| docetaxelgiven in combination with epirubicin or capecitabine | Drug | A, B |
| epirubicinfor patients with locally advanced breast cancer, or metastatic breast cancer not previously treated with anthracyclines | Drug | A, B |
| capecitabinefor metastatic breast cancer patients previously treated with anthracyclines | Drug | A, B |
Primary outcome
quality of life
Time frame: during first 6 weeks of chemotherapy
3 secondary outcomes
Response rate
Time frame: After 12 and 24 weeks of chemotherapy
Toxicity
Time frame: every 3 weeks
overall survival
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2016.
- Results publication: PubMed 21324184Nuzzo F, Morabito A, Gravina A, Di Rella F, Landi G, Pacilio C, Labonia V, Rossi E, De Maio E, Piccirillo MC, D'Aiuto G, Thomas R, Rinaldo M, Botti G, Di Bonito M, Di Maio M, Gallo C, Perrone F, de Matteis A. Effects on quality of life of weekly docetaxel-based chemotherapy in patients with locally advanced or metastatic breast cancer: results of a single-centre randomized phase 3 trial. BMC Cancer. 2011 Feb 16;11:75. doi: 10.1186/1471-2407-11-75.
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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.
Andrea de Matteis, M.D. principal investigator
NCI Naples, Division of Medical Oncology C
Francesco Perrone, M.D., Ph.D. principal investigator
NCI Naples, Clinical Trials Office
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing docetaxel, epirubicin and capecitabine in people with Breast Cancer, run by National Cancer Institute, Naples at 3 sites in Italy.
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 5 inclusion and 11 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: finished, as of the sponsor's last update on 14 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Italy. 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 phase mean?
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 (time frame: during first 6 weeks of chemotherapy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00540800, which also lists 1 linked publication.
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 Jan 2016.