Breast CancerPhase 2HIST-RICNCT02679040
Histological Response Rate After Mastectomy and Immediate Breast Reconstruction at the End of Neoadjuvant Chemotherapy and Radiotherapy
A Phase 2 study testing Immediate mammary reconstruction, Chemotherapy and Radiation therapy in people with Breast Cancer, run by Institut Paoli-Calmettes at 10 sites in France.
Trial summary
At present, it is widely admitted not proposing immediate mammary reconstruction when an adjuvant radiotherapy is indicated because of the significant change of the cosmetic result (profit) and it whatever is the technique of reconstruction adopted. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Immediate mammary reconstruction, Chemotherapy and Radiation therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 101 participants
- Where
- 10 sitesFrance
- Study dates
- 27 Jan 2016to Feb 2025
- Phase
- Phase 2
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age > 18 years,
- Infiltrating carcinoma,
- Neoadjuvant chemotherapy indication,
- Radiotherapy indication,
- 0 or 1 score Performance status (WHO),
- Signed informed consent,
- Affiliation to Social Security System
Who cannot join
- Lobular carcinoma,
- "Luminal A" Tumor (RH+ and Her2 negative with grade I, and tumor RH+ Her2 negative with grade II and with Ki67<20%),
- Attempt of first conservative treatment,
- Metastatic breast cancer,
- Inflammatory carcinoma,
- History of homolateral or controlateral mammary carcinoma,
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- Progression disease (despite neoadjuvant chemotherapy),
- Contraindications in an immediate mammary reconstruction by scrap of big dorsal (comorbidity),
- Any psychological, familial, sociological or geographical condition-potentially hampering compliance with the study protocol or follow-up schedule,
- Patients deprived of liberty or placed under the authority of a tutor.
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
France10 sites
Institut Paul Papin
Angers
Polyclinique Urbain V
Avignon
Capio-Clinique Belharra
Bayonne
Institut Bergonie
Bordeaux
Centre Jean Perrin
Clermont-Ferrand
Institut Oscar Lambret
Lille
Institut Paoli-Calmettes
Marseille, Bouches-du-Rhône, 13273
Clinique Clementville
Montpellier
Icm - Institut Regional Du Cancer de Montpellier
Montpellier
Institut Jean Godinot
Reims
About this study
At present, it is widely admitted not proposing immediate mammary reconstruction when an adjuvant radiotherapy is indicated because of the significant change of the cosmetic result (profit) and it whatever is the technique of reconstruction adopted. This is true all the more as it is about a reconstruction by prosthesis because of the prothetic died risk of hull(shell).
Teams proposed immediate mammary reconstructions to expanding (carrier) patients of carcinoma infiltrating, sometimes locally moved forward. For these patients, was not brought back(reported) by increase of the risk of local or remote relapse.
Read more
Two studies estimated afterward the feasibility of the mastectomy with immediate mammary reconstruction at the close of the chemotherapy and of the radiotherapy. The rate of morbidity is judged as acceptable. The rate of local second offense(recurrence) was similar to the patients benefiting from the classic therapeutic plan.
During an other study ( M-RIC), it was shown that the inversion of therapeutic sequence is possible and that by prescribing the chemotherapy and the radiotherapy before immediate mammary reconstruction, the morbidity is acceptable.
It is acquired that the chemotherapy néoadjuvant is equivalent to the post-operative chemotherapy as regards the global survival.
On the other hand, the rate of histological answer, according to subgroups, is very different. This rate can vary of 9 % for tumors RH +, negative Her2 in 45 % for tumors RH-, Her2 over expression. There are 33 % for the RH +, Her2 + and of 35 % for triple-negative.
The purpose of the investigators study is to estimate the rate of histological response during the inversion of therapeutic sequence to make sure of the oncologic safety(security), in particular by molecular subgroups, considering the heterogeneousness of the results(profits) after chemotherapy néoadjuvant only. Sataloff and Chevallier Classifications is the references and will be used here, but the investigators can also use Symmans classification in addition.
The rate of local and metastatic second offenses(recurrences) will also be estimated.
- Conditions
- Breast Cancer
- Being tested
- Immediate mammary reconstruction, Chemotherapy, Radiation therapy
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Immediate mammary reconstructionProcedure or surgery
Chemotherapy administration then radiotherapy and then surgery : mastectomy and immediate mammary reconstruction.
ChemotherapyDrug
Also called anthracyclines and taxotere with or without Herceptin
Chemotherapy treatment
Radiation therapyRadiation
Radiation therapy
| Study group | Role | What they receive |
|---|---|---|
| Immediate Mammary Reconstruction | Experimental | Chemotherapy, radiation therapy, mastectomy with immediate mammary reconstruction Receives: Procedure: Immediate mammary reconstruction; Drug: Chemotherapy; Radiation: Radiation therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of histological response of an infiltrating tumor within various molecular subgroups
Tumor Histological response (group RH+ Her2+, group RH+ Her2-, group RH- Her2+, and group RH- Her2-)
Measured: from surgery up to 1 month
Secondary outcomes (1)
Rate of ganglionar response on the axillary lymph nodes after chemotherapy and radiotherapy néoadjuvant
Number of lymph nodes collected and number of positive lymph nodes
Measured: from surgery up to 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2016 (estimated)
- Study start27 Jan 2016
- Primary completion29 Mar 2021
- Study completionFeb 2025 (estimated)
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 Institut Paoli-CalmettesThe 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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 101 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut Paoli-Calmettes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- BANNIER Marie, MD, PhD, Principal investigator, Institut Paoli-Calmettes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02679040
- Sponsor's protocol ID
- HIST-RIC-IPC 2014-014
- Acronym
- HIST-RIC
- Status last verified
- Jun 2023
- First submitted
- 25 Jan 2016
- Last updated
- 3 Jul 2023
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Histological Response Rate After Mastectomy and Immediate Breast Reconstruction at the End of Neoadjuvant Chemotherapy and Radiotherapy
- ClinicalTrials.gov ID
- NCT02679040
- Acronym / sponsor ID
- HIST-RIC / HIST-RIC-IPC 2014-014
- Conditions
- Breast Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 101 participants (actual)
- Lead sponsor
- Institut Paoli-CalmettesUniversity, hospital or other
- Study start
- 27 Jan 2016 (actual)
- Primary completion
- 29 Mar 2021 (actual)
- Study completion
- Feb 2025 (estimated)
- First posted
- 10 Feb 2016 (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.
At present, it is widely admitted not proposing immediate mammary reconstruction when an adjuvant radiotherapy is indicated because of the significant change of the cosmetic result (profit) and it whatever is the technique of reconstruction adopted. This is true all the more as it is about a reconstruction by prosthesis because of the prothetic died risk of hull(shell).
Teams proposed immediate mammary reconstructions to expanding (carrier) patients of carcinoma infiltrating, sometimes locally moved forward. For these patients, was not brought back(reported) by increase of the risk of local or remote relapse.
Two studies estimated afterward the feasibility of the mastectomy with immediate mammary reconstruction at the close of the chemotherapy and of the radiotherapy. The rate of morbidity is judged as acceptable. The rate of local second offense(recurrence) was similar to the patients benefiting from the classic therapeutic plan.
During an other study ( M-RIC), it was shown that the inversion of therapeutic sequence is possible and that by prescribing the chemotherapy and the radiotherapy before immediate mammary reconstruction, the morbidity is acceptable.
It is acquired that the chemotherapy néoadjuvant is equivalent to the post-operative chemotherapy as regards the global survival.
On the other hand, the rate of histological answer, according to subgroups, is very different. This rate can vary of 9 % for tumors RH +, negative Her2 in 45 % for tumors RH-, Her2 over expression. There are 33 % for the RH +, Her2 + and of 35 % for triple-negative.
The purpose of the investigators study is to estimate the rate of histological response during the inversion of therapeutic sequence to make sure of the oncologic safety(security), in particular by molecular subgroups, considering the heterogeneousness of the results(profits) after chemotherapy néoadjuvant only. Sataloff and Chevallier Classifications is the references and will be used here, but the investigators can also use Symmans classification in addition.
The rate of local and metastatic second offenses(recurrences) will also be estimated.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Immediate Mammary Reconstruction | Experimental | Procedure: Immediate mammary reconstruction, Drug: Chemotherapy, Radiation: Radiation therapyChemotherapy, radiation therapy, mastectomy with immediate mammary reconstruction |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age > 18 years,
- Infiltrating carcinoma,
- Neoadjuvant chemotherapy indication,
- Radiotherapy indication,
- 0 or 1 score Performance status (WHO),
Key exclusion criteria (10 listed)
- Lobular carcinoma,
- "Luminal A" Tumor (RH+ and Her2 negative with grade I, and tumor RH+ Her2 negative with grade II and with Ki67<20%),
- Attempt of first conservative treatment,
- Metastatic breast cancer,
- Inflammatory carcinoma,
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 |
|---|---|---|
| Immediate mammary reconstructionChemotherapy administration then radiotherapy and then surgery : mastectomy and immediate mammary reconstruction. | Procedure or surgery | Immediate Mammary Reconstruction |
| ChemotherapyAlso: anthracyclines and taxotere with or without HerceptinChemotherapy treatment | Drug | Immediate Mammary Reconstruction |
| Radiation therapyRadiation therapy | Radiation | Immediate Mammary Reconstruction |
Primary outcome
Rate of histological response of an infiltrating tumor within various molecular subgroups
Time frame: from surgery up to 1 month
Tumor Histological response (group RH+ Her2+, group RH+ Her2-, group RH- Her2+, and group RH- Her2-)
1 secondary outcome
Rate of ganglionar response on the axillary lymph nodes after chemotherapy and radiotherapy néoadjuvant
Time frame: from surgery up to 1 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2023.
- Institut paoli-calmettesLink provided by the sponsor.
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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.
BANNIER Marie, MD, PhD principal investigator
Institut Paoli-Calmettes
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Immediate mammary reconstruction, Chemotherapy and Radiation therapy in people with Breast Cancer, run by Institut Paoli-Calmettes at 10 sites in France.
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 7 inclusion and 10 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 3 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in France. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Rate of histological response of an infiltrating tumor within various molecular subgroups (time frame: from surgery up to 1 month). 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 3 Jul 2023.