Breast CancerPhase 3NCT00289263
Maintenance Chemotherapy in Metastatic Breast Cancer
A Phase 3 study testing Paclitaxel in people with Breast Cancer, run by MANTA 1 Study Italian Collaborative Group at 7 sites in Italy.
Trial summary
This is a randomized, prospective and multicenter phase III study. Two-hundred-sixty-two (262) patients on each arm will be recruited in the study. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Paclitaxel
- How many people
- 524 participants
- Where
- 7 sitesItaly
- Study dates
- Apr 1998to Oct 2003
- 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 18 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Written informed consent.
- Patients with metastatic breast cancer in response or stable disease after six to eight courses of first line induction chemotherapy treatment
- Measurable and/or evaluable disease
- Performance status ECOG 0, 1, 2.
- Normal cardiac function, confirmed by left ventricular ejection fraction (LVEF).
Who cannot join
- Presence of peripheral neuropathy > grade 2 by NCI Common Toxicity Criteria (NCI-CTC) following induction chemotherapy
- Adjuvant taxane-based therapy
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
Italy7 sites
Oncology Institute
Bari, 70010
Morgagni-Pierantoni Hospital
Forlì, 47100
National Cancer Research Institute
Genoa
Azienda Ospedaliera Pisana
Pisa, PI, 56100
S. Carlo Hospital
Potenza
Santa Maria Nuova Hospital
Reggio Emilia
University of Rome
Rome
About this study
Official title: Maintenance Paclitaxel Vs Control After Anthracycline/Paclitaxel Combined First-Line Chemotherapy in Metastatic Breast Cancer
This is a randomized, prospective and multicenter phase III study. Two-hundred-sixty-two (262) patients on each arm will be recruited in the study.
Read the detailed description
The primary objective is time to disease progression. All patients must be treated with first line chemotherapy, consisting of one of the following regimens: a) ET (epirubicin 90 mg/sqm day 1 plus paclitaxel 200 mg/sqm (3 hour infusion) day 1, or b) AT (doxorubicin 50 mg/sqm day 1 plus paclitaxel 200 mg/sqm (3 hour infusion) day 2, administered on a 3 weekly schedule.
Patients with complete response, partial response or stable disease are eligible for MANTA1 study.
The expected median progression free survival of metastatic breast cancer patients who achieve a disease control after first line chemotherapy was estimated to be 10 months. The minimal improvement, justifying the adoption of maintenance paclitaxel, was estimated to be at least 3 months. With 262 eligible patients on each arm, the trial will have a power of 80% to detect a 30% improvement in median progression free survival, testing at the two-sided .05 significance level.
- Conditions
- Breast Cancer
- Being tested
- Paclitaxel
- Keywords
- metastatic breast cancer, maintenance chemotherapy
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PaclitaxelDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to disease progression with maintenance paclitaxel versus observation
Secondary outcomes (4)
Overall survival
Toxicity
Quality of live
Conversion to a better response
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2006 (estimated)
- Study startApr 1998
- Study completionOct 2003
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.
- 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
- Single group
- Masking
- None (open label)
- Enrolment
- 524 participants
Sponsor and investigators
- Lead sponsor
- MANTA 1 Study Italian Collaborative Group
- Sponsor type
- University, hospital or other
- Collaborators
- Bristol-Myers Squibb
- Investigators
- PierFranco Conte, MD, Principal investigator, University of Modena, ItalyDino Amadori, MD, Principal investigator, Morgagni-Pierantoni Hospital, Forli, ItalyMario Delena, MD, Principal investigator, Oncology Institute, Bari, Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00289263
- Sponsor's protocol ID
- MANTA1
- Status last verified
- Nov 2003
- First submitted
- 8 Feb 2006
- Last updated
- 9 Feb 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Maintenance Paclitaxel Vs Control After Anthracycline/Paclitaxel Combined First-Line Chemotherapy in Metastatic Breast Cancer
- ClinicalTrials.gov ID
- NCT00289263
- Acronym / sponsor ID
- MANTA1
- Conditions
- Breast Cancer
- Keywords
- metastatic breast cancer, maintenance chemotherapy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 524 participants
- Lead sponsor
- MANTA 1 Study Italian Collaborative GroupUniversity, hospital or other
- Collaborators
- Bristol-Myers Squibb
- Study start
- Apr 1998
- Study completion
- Oct 2003
- First posted
- 9 Feb 2006 (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 is a randomized, prospective and multicenter phase III study. Two-hundred-sixty-two (262) patients on each arm will be recruited in the study.
Detailed description
The primary objective is time to disease progression. All patients must be treated with first line chemotherapy, consisting of one of the following regimens: a) ET (epirubicin 90 mg/sqm day 1 plus paclitaxel 200 mg/sqm (3 hour infusion) day 1, or b) AT (doxorubicin 50 mg/sqm day 1 plus paclitaxel 200 mg/sqm (3 hour infusion) day 2, administered on a 3 weekly schedule.
Patients with complete response, partial response or stable disease are eligible for MANTA1 study.
The expected median progression free survival of metastatic breast cancer patients who achieve a disease control after first line chemotherapy was estimated to be 10 months. The minimal improvement, justifying the adoption of maintenance paclitaxel, was estimated to be at least 3 months. With 262 eligible patients on each arm, the trial will have a power of 80% to detect a 30% improvement in median progression free survival, testing at the two-sided .05 significance level.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Written informed consent.
- Patients with metastatic breast cancer in response or stable disease after six to eight courses of first line induction chemotherapy treatment
- Measurable and/or evaluable disease
- Performance status ECOG 0, 1, 2.
- Normal cardiac function, confirmed by left ventricular ejection fraction (LVEF).
Key exclusion criteria (2 listed)
- Presence of peripheral neuropathy > grade 2 by NCI Common Toxicity Criteria (NCI-CTC) following induction chemotherapy
- Adjuvant taxane-based therapy
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 |
|---|---|---|
| Paclitaxel | Drug | – |
Primary outcome
Time to disease progression with maintenance paclitaxel versus observation
4 secondary outcomes
Overall survival
Toxicity
Quality of live
Conversion to a better response
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2006.
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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.
PierFranco Conte, MD principal investigator
University of Modena, Italy
Dino Amadori, MD principal investigator
Morgagni-Pierantoni Hospital, Forli, Italy
Mario Delena, MD principal investigator
Oncology Institute, Bari, Italy
7 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 Paclitaxel in people with Breast Cancer, run by MANTA 1 Study Italian Collaborative Group at 7 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 2 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: status not confirmed, as of the sponsor's last update on 9 Feb 2006. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 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?
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?
Time to disease progression with maintenance paclitaxel versus observation. 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 9 Feb 2006.