Inflammatory Breast CancerPhase 3PEGASE07NCT02324088
Interest of Maintenance Chemotherapy After Induction Treatment for Inflammatory Breast Cancer
A Phase 3 study testing Docetaxel, Cyclophosphamide and Epirubicin in people with Inflammatory Breast Cancer, run by UNICANCER.
Trial summary
To evaluate the benefit of adding docetaxel-5 fluorouracile (D-5FU) regimen after pre-operative epirubicin-cyclophosphamide (EC) and loco-regional treatment in inflammatory breast cancer (IBC). Read more about this study
- Who is it for?
- Ages 18 to 60 years, women only
- Conditions the study is for
- Inflammatory Breast Cancer
- What is being tested?
- Docetaxel, Cyclophosphamide and Epirubicin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 174 participants
- Where
- No sites listed yet
- Study dates
- Oct 2000to Jan 2015
- 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 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- histologically proven breast cancer
- inflammatory breast cancer
- no metastatic site
- age > or = 18 and < or = 60
- OMS score: 0, 1, 2
- life expectancy > or = 3 months
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- Normal (isotopic or ultrasonography) left ventricular ejection fraction
- Normal haematological, liver, and kidney functions
- patients who gave their written informed consent.
Who cannot join
- non inflammatory breast tumour with a cutaneous permeation nodule
- presence of a metastatic site
- medical history of a cancerous tumour except for carcinoma in situ of the uterine cervix, a basal cell skin cancer, or a breast carcinoma on the contralateral side
- patients having already had a chemotherapy, a radiotherapy, or an hormone therapy for this breast tumour
- medical history of congestive heart failure even medically controlled
- medical history of myocardial infarction during the 6 months before the inclusion in the study
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- active infection or other severe underlying pathology which could possibly prevent the patient from receiving treatments
- administration of another chemotherapy during the study
- pregnant or breast feeding patients (the patients of childbearing age must be placed under efficient contraception)
- patients whose social or psychological state does not allow to consider a correct adherence to the treatment and to the required medical follow-up
- WHO score 3,4
- unbalanced diabetes
- polysorbate 80 allergy
About this study
Official title: Phase III Trial Assessing the Interest of a Maintenance Chemotherapy Combining Docetaxel (Taxotere) 5-FU After Induction Treatment by Aintensive Chemotherapy for Inflammatory Breast Cancers
To evaluate the benefit of adding docetaxel-5 fluorouracile (D-5FU) regimen after pre-operative epirubicin-cyclophosphamide (EC) and loco-regional treatment in inflammatory breast cancer (IBC).
- Conditions
- Inflammatory Breast Cancer
- Being tested
- Docetaxel, Cyclophosphamide, Epirubicin
- Medical subject headings
- Inflammatory Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DocetaxelDrug
CyclophosphamideDrug
EpirubicinDrug
| Study group | Role | What they receive |
|---|---|---|
| Arm A | Active comparator | 4 cycles of high-dose EC (E150 mg/m² and C 4000 mg/m² every 3 weeks) then mastectomy with axillary lymph node dissection and radiotherapy Receives: Drug: Cyclophosphamide; Drug: Epirubicin |
| Arm B | Experimental | 4 cycles of high-dose EC (E150 mg/m² and C 4000 mg/m² every 3 weeks) then mastectomy with axillary lymph node dissection and radiotherapy followed by 4 cycles of D-5FU (D 85 mg/m², day 1 and 5FU 2500 mg/m²/day continuous infusion, days 1-5 every 3 weeks) Receives: Drug: Docetaxel; Drug: Cyclophosphamide; Drug: Epirubicin |
What is being measured
The primary outcome is the main question the study is designed to answer.
disease-free survival rate
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2014 (estimated)
- Study startOct 2000
- Primary completionDec 2012
- Study completionJan 2015
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 Inflammatory Breast CancerStudies of the same condition, open and under way.
- More trials run by UNICANCERThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 174 participants (actual)
Sponsor and investigators
- Lead sponsor
- UNICANCER
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Patrice Viens, MD, Principal investigator, Institut Paoli Calmette Marseille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02324088
- Sponsor's protocol ID
- PEGASE 7/0002
- Acronym
- PEGASE07
- Status last verified
- Feb 2021
- First submitted
- 14 Dec 2014
- Last updated
- 21 Feb 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Unicancer will share de-identified individual data that underlie the results reported. A decision concerning the sharing of other study documents, including protocol and statistical analysis plan will be examined upon request.
Publications
Goncalves A, Pierga JY, Ferrero JM, Mouret-Reynier MA, Bachelot T, Delva R, Fabbro M, Lerebours F, Lotz JP, Linassier C, Dohollou N, Eymard JC, Leduc B, Lemonnier J, Martin AL, Boher JM, Viens P, Roche H. UNICANCER-PEGASE 07 study: a randomized phase III trial evaluating postoperative docetaxel-5FU regimen after neoadjuvant dose-intense chemotherapy for treatment of inflammatory breast cancer. Ann Oncol. 2015 Aug;26(8):1692-7. doi: 10.1093/annonc/mdv216. Epub 2015 May 5.
PubMed 25943350
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase III Trial Assessing the Interest of a Maintenance Chemotherapy Combining Docetaxel (Taxotere) 5-FU After Induction Treatment by Aintensive Chemotherapy for Inflammatory Breast Cancers
- ClinicalTrials.gov ID
- NCT02324088
- Acronym / sponsor ID
- PEGASE07 / PEGASE 7/0002
- Conditions
- Inflammatory Breast Cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 174 participants (actual)
- Lead sponsor
- UNICANCERUniversity, hospital or other
- Study start
- Oct 2000
- Primary completion
- Dec 2012 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 24 Dec 2014 (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.
To evaluate the benefit of adding docetaxel-5 fluorouracile (D-5FU) regimen after pre-operative epirubicin-cyclophosphamide (EC) and loco-regional treatment in inflammatory breast cancer (IBC).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A | Active comparator | Drug: Cyclophosphamide, Drug: Epirubicin4 cycles of high-dose EC (E150 mg/m² and C 4000 mg/m² every 3 weeks) then mastectomy with axillary lymph node dissection and radiotherapy |
| Arm B | Experimental | Drug: Docetaxel, Drug: Cyclophosphamide, Drug: Epirubicin4 cycles of high-dose EC (E150 mg/m² and C 4000 mg/m² every 3 weeks) then mastectomy with axillary lymph node dissection and radiotherapy followed by 4 cycles of D-5FU (D 85 mg/m², day 1 and 5FU 2500 mg/m²/day continuous infusion, days 1-5 every 3 weeks) |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- histologically proven breast cancer
- inflammatory breast cancer
- no metastatic site
- age > or = 18 and < or = 60
- OMS score: 0, 1, 2
Key exclusion criteria (13 listed)
- non inflammatory breast tumour with a cutaneous permeation nodule
- presence of a metastatic site
- medical history of a cancerous tumour except for carcinoma in situ of the uterine cervix, a basal cell skin cancer, or a breast carcinoma on the contralateral side
- patients having already had a chemotherapy, a radiotherapy, or an hormone therapy for this breast tumour
- medical history of congestive heart failure even medically controlled
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 |
|---|---|---|
| Docetaxel | Drug | Arm B |
| Cyclophosphamide | Drug | Arm A, Arm B |
| Epirubicin | Drug | Arm A, Arm B |
Primary outcome
disease-free survival rate
Time frame: 3 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 21 Feb 2021.
- Results publication: PubMed 25943350Goncalves A, Pierga JY, Ferrero JM, Mouret-Reynier MA, Bachelot T, Delva R, Fabbro M, Lerebours F, Lotz JP, Linassier C, Dohollou N, Eymard JC, Leduc B, Lemonnier J, Martin AL, Boher JM, Viens P, Roche H. UNICANCER-PEGASE 07 study: a randomized phase III trial evaluating postoperative docetaxel-5FU regimen after neoadjuvant dose-intense chemotherapy for treatment of inflammatory breast cancer. Ann Oncol. 2015 Aug;26(8):1692-7. doi: 10.1093/annonc/mdv216. Epub 2015 May 5.
- Individual participant dataSharing planned: Yes. Unicancer will share de-identified individual data that underlie the results reported. A decision concerning the sharing of other study documents, including protocol and statistical analysis plan will be examined upon request.
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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.
Patrice Viens, MD principal investigator
Institut Paoli Calmette Marseille
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Docetaxel, Cyclophosphamide and Epirubicin in people with Inflammatory Breast Cancer, run by UNICANCER.
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 9 inclusion and 13 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 21 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
disease-free survival rate (time frame: 3 years). 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 NCT02324088, 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 21 Feb 2021.