Histological Response Rate After Mastectomy and Immediate Breast Reconstruction at the End of Neoadjuvant Chemotherapy and Radiotherapy
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 101
- 试验地点
- 10
- 主要终点
- Rate of histological response of an infiltrating tumor within various molecular subgroups
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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,
- •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.
研究组 & 干预措施
Immediate Mammary Reconstruction
Chemotherapy, radiation therapy, mastectomy with immediate mammary reconstruction
干预措施: Immediate mammary reconstruction (Procedure)
Immediate Mammary Reconstruction
Chemotherapy, radiation therapy, mastectomy with immediate mammary reconstruction
干预措施: Chemotherapy (Drug)
Immediate Mammary Reconstruction
Chemotherapy, radiation therapy, mastectomy with immediate mammary reconstruction
干预措施: Radiation therapy (Radiation)
结局指标
主要结局
Rate of histological response of an infiltrating tumor within various molecular subgroups
时间窗: from surgery up to 1 month
Tumor Histological response (group RH+ Her2+, group RH+ Her2-, group RH- Her2+, and group RH- Her2-)
次要结局
- Rate of ganglionar response on the axillary lymph nodes after chemotherapy and radiotherapy néoadjuvant(from surgery up to 1 month)