Breast Cancer Organelle Properties and Protein Expression Atlas in the Three Immunohistochemical Subtypes of Breast Cancers
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 1,050
- 试验地点
- 1
- 主要终点
- The amount of fatty acids accumulated in lipid droplets, quantified by the total intensity of a lipid-droplet specific fluorescent dye in the four cohorts
研究概览
简要总结
This trial is a translational, open-label, monocentric and prospective cohort study of participants with breast cancer aiming to create a combined ESPRESSO (= organelle properties) phenotype and spatial proteomics data collection encompassing four cohorts:
- TN eBC = cohort A,
- HER2+ eBC = cohort B,
- Luminal eBC = cohort C,
- dnMBC = cohort D. In total 1050 participants will be enrolled in the study. Laboratory analysis (including ESPRESSO technique) will be conducted on the biological specimen collected during this study.
The primary objective is to describe the amount of fatty acids accumulated in lipid droplets, within the four cohorts. As a secondary objective, the analysis will expand to other organelles like lysosomal acidity and nuclear organization.
The study is due to last 9 years (4 years of recruitment and 5 years of study participation)
详细描述
The study targets participants with early breast cancer (eBC) or de novo metastatic breast cancer (dnMBC) who will be treated within a standard of care procedure or a clinical trial.
Following informed consent form signature, participants will be included in the study protocol and will be assigned in one of four cohorts, depending on the immunohistochemical subtype of tumor.
Patients will be enrolled concomitantly in each cohort, with the following recruitment goals:
- Cohort A (N = 300 patients): Triple Negative eBC (TN eBC)
- Cohort B (N = 300 patients): HER2+ eBC (HR+ or HR-)
- Cohort C (N = 300 patients): Luminal eBC (Luminal A or B)
- Cohorte D (N = 150 patients): dnMBC of any subtype (TN, HER2+ or Luminal).
After the cancer treatment completion, the participants will remain in the study for a follow-up period (study participation will be 5 years maximum since baseline).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Inclusion Criteria:
- •Patient (women or men) with histologically documented breast cancer
- •Early Breast Cancer (eBC) or de novo metastatic BC (dnMBC), regardless the immunohistochemical subtype: Triple Negative BC (ER-negative [<10%], PR-negative [<10%] and HER2-negative [i.e. null, ultra-low or low] BC); HER2-positive BC: HER2 overexpression score 3+ or ERBB2 amplification whatever ER/PR expression and proliferation level; Luminal A-like BC: low to moderately proliferative (Ki67<20%) ER-positive (≥ 10%) PR-positive (≥ 20%) BC and low proliferative (Ki67< 14%) ER-positive PR-negative (< 20%) BC; Luminal B-like BC: highly proliferative (Ki67≥ 20%) ER-positive, PR-positive BC or moderately proliferative (14% ≤ Ki67< 20%) ER-positive PR-negative (<20%) BC
- •Age ≥ 18 years at the time of study entry
- •Patient followed within a standard of care procedure or clinical trial
- •ECOG performance status ≤ 2
- •Breast cancer treatment not yet started
- •Patient able to participate and willing to give informed consent prior performance of any study-related procedures and to comply with the study protocol
- •Patient affiliated to a Social Health Insurance in France.
排除标准
- •Known history of positive test for Hepatitis B virus or Hepatitis C virus or Immunodeficiency Virus (HIV) or Hanta virus.
- •Abnormal coagulation contraindicating biopsy
- •Previous or on going treatment for the breast cancer
- •Bone metastases when this is the only site of biopsiable disease for dnMBC patients
- •Any condition contraindicated with blood sampling procedures required by the protocol (including Hemoglobin < 8g/dl)
- •Patients with known additional malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin or squamous cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical cancer
- •Patient pregnant, or breast-feeding
- •Any psychological, familial, geographic or social situation, according to the judgment of investigator, potentially preventing the provision of informed consent or compliance to study procedure.
- •Patient who has forfeited his/her freedom by administrative or legal award or who is under guardianship.
研究组 & 干预措施
Early breast cancer (triple negative, HER2+, luminal) with indication of neo-adjuvant treatment
-
The following samples will be collected during the study :
-
Tumor sample (primitive tumor ± metastatic axillary lymph node) at: baseline, surgery, 1st recurrence
-
Blood samples at: baseline, mid-course of neo-adjuvant treatment, before and after surgery, end of systemic adjuvant treatment, every 6 or 12 months until the 1st recurrence or during 5 year follow-up period, following progressions/recurrences
-
Ascite and pleural fluid (when a puncture procedure is performed for clinical purposes) at: 1st recurrence, following progressions/recurrences
-
Data collection will be performed at baseline and then at each time point planned in the center for clinical standard of care assessment or clinical trial until end of participation (5 years from baseline at maximum). It will include tumor response and adverse event assessments (AE related to study procedures only)
干预措施: Tumor biopsy (Other)
Early breast cancer (triple negative, HER2+, luminal) without indication of neo-adjuvant treatment
-
The following samples will be collected during the study :
-
Tumor sample (primitive tumor ± metastatic axillary lymph node) at: baseline, surgery, 1st recurrence
-
Blood samples at: baseline (= before surgery), after surgery, end of adjuvant chemotherapy, end of other systemic adjuvant treatment, every 6 or 12 months until the 1st recurrence or during 5 year follow-up period, following progressions/recurrences
-
Ascite and pleural fluid (when a puncture procedure is performed for clinical purposes) at: 1st recurrence, following progressions/recurrences
-
Data collection will be performed at baseline and then at each time point planned in the center for clinical standard of care assessment or clinical trial until end of participation (5 years from baseline at maximum). It will include tumor response and adverse event assessments (AE related to study procedures only)
干预措施: Tumor biopsy (Other)
De novo metastatic breast cancer (triple negative, HER2+, luminal)
-
The following samples will be collected during the study :
-
Tumor sample (primitive tumor ± metastatic axillary lymph node) at: baseline, surgery, 1st progression
-
Blood samples at: baseline, 1st progression, following progressions
-
Ascite and pleural fluid (when a puncture procedure is performed for clinical purposes) at: baseline, 1st progression, following progressions
-
Data collection will be performed at baseline and then at each time point planned in the center for clinical standard of care assessment or clinical trial until end of participation (5 years from baseline at maximum). It will include tumor response and adverse event assessments (AE related to study procedures only)
干预措施: Tumor biopsy (Other)
结局指标
主要结局
The amount of fatty acids accumulated in lipid droplets, quantified by the total intensity of a lipid-droplet specific fluorescent dye in the four cohorts
时间窗: 5 years for each participant
次要结局
- Pathological response will be assessed using residual cancer burden (RCB) index 17(5 years for each participant)
- Event-free survival (EFS) is defined as the time from inclusion until relapse (local, regional or distant) or death from any cause for eBC.(5 years of each participant)
- First line Progression-free survival (PFS1) is defined as the time from inclusion until progression or death from any cause for dnMBC(5 years for each participant)