ENCORE: Multicenter ProspectivE Registry of Sequential ANtibody Drug COnjugates (ADCs) in HER2 Negative Metastatic BREast Cancer (MBC)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Real-world progression free survival (rwPFS) of first line ADC (ADC1)
研究概览
简要总结
Antibody-drug conjugates (ADCs) have demonstrated substantial improvement in progression free survival (PFS) and overall survival (OS) in phase III clinical trials in patients with metastatic triple negative breast cancer (mTNBC) and hormone receptor positive/HER2 negative (HR+/HER2-) metastatic breast cancer (MBC), offering an effective new treatment strategy. Several outstanding questions drive the decision to use ADC drugs clinically. This is a prospective, multi-site observational study of patients with metastatic breast cancer (mBC) who are being treated with FDA-approved antibody drug conjugates (ADCs) as part of routine care and aims to collect real-world data to evaluate the impact of ADC treatment as part of routine care.
详细描述
PRIMARY OBJECTIVES:
I. Real-world progression free survival (rwPFS) of the first line of ADC under routine care (ADC1) by investigator assessment II. Real-world progression free survival (rwPFS) of the second line ADC under routine care (ADC2) by investigator assessment
SECONDARY OBJECTIVES:
I. To evaluate the efficacy of ADC1 and ADC2 as measured by duration of response (DOR), best overall response (BOR), disease control rate (DCR), and overall survival (OS) for each ADC.
II. To evaluate key safety parameters for ADC1 and ADC2 by chart review.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female patients aged 18 years or greater with ability to provide written informed consent for this prospective registry study.
- •Estimated life expectancy of at least at 3 months per investigator assessment.
- •Willingness to provide an archival tissue sample and blood samples (20cc research blood collection at several timepoints) for research purposes.
- •Cohort-specific enrollment criteria:
- •Cohort 1: Histologically documented HR+/HER2- MBC with plan to start an FDA-approved ADC as their first ADC per standard of care (SOC).
- •Cohort 2: Histologically documented metastatic TNBC with plan to start an FDA-approved ADC as their first ADC per standard of care
- •Cohort 3: Histologically documented HR+/HER2- MBC with plan to start an FDA-approved ADC as their second ADC per standard of care (ADC1 should be an approved ADC administered per SOC or as monotherapy in a clinical trial; no prior experimental ADCs allowed). Clinical data from the first ADC must be available for retrospective review.
- •Cohort 4: Histologically documented metastatic TNBC with plan to start an FDA-approved ADC as their second ADC per standard of care (ADC1 should be an approved ADC administered per standard of care or as monotherapy in a clinical trial; no prior experimental ADCs allowed). Clinical data from the first ADC must be available for retrospective review.
- •Measurable disease is not required for any cohort.
排除标准
- •Prior receipt of an experimental ADC in the metastatic setting. Of note, patients who received an FDA-approved ADC as their first ADC (as monotherapy, not in combination) can participate in cohorts 3 or 4 prior to starting their second FDA-approved ADC per standard of care. Of note, for all cohorts, experimental therapies are not allowed as intervening therapies after starting ADC
- •If a patient enrolls on a clinical trial of an experimental therapy after ADC1, they will be taken off study.
- •Current participation in a clinical trial with an ADC.
- •Contraindication to research phlebotomy to collect ~20cc blood at each research blood draw timepoint.
研究组 & 干预措施
Cohort 1: HR+/HER2- mBC participants enrolled before first line ADC (ADC1))
Participants with histologically documented HR+/HER2- MBC with a plan to start an FDA-approved ADC as a first ADC per usual care will be enrolled before beginning any ADC. Participants will have blood samples obtained during routine clinical visits during ADC1 and ADC2, if applicable.
干预措施: Specimen collection (Procedure)
Cohort 1: HR+/HER2- mBC participants enrolled before first line ADC (ADC1))
Participants with histologically documented HR+/HER2- MBC with a plan to start an FDA-approved ADC as a first ADC per usual care will be enrolled before beginning any ADC. Participants will have blood samples obtained during routine clinical visits during ADC1 and ADC2, if applicable.
干预措施: Non-Investigational Antibody-Drug Conjugates (ADC) (Drug)
Cohort 1: HR+/HER2- mBC participants enrolled before first line ADC (ADC1))
Participants with histologically documented HR+/HER2- MBC with a plan to start an FDA-approved ADC as a first ADC per usual care will be enrolled before beginning any ADC. Participants will have blood samples obtained during routine clinical visits during ADC1 and ADC2, if applicable.
干预措施: Medical Record Review (Other)
Cohort 2: Metastatic Triple Negative Breast Cancer (mTNBC) participants enrolled before ADC1
Participants with histologically documented metastatic TNBC with a plan to start an FDA-approved ADC as their first ADC per usual care will be enrolled before beginning any ADC. Participants will have blood samples obtained during routine clinical visits during ADC1 and ADC2, if applicable.
干预措施: Specimen collection (Procedure)
Cohort 2: Metastatic Triple Negative Breast Cancer (mTNBC) participants enrolled before ADC1
Participants with histologically documented metastatic TNBC with a plan to start an FDA-approved ADC as their first ADC per usual care will be enrolled before beginning any ADC. Participants will have blood samples obtained during routine clinical visits during ADC1 and ADC2, if applicable.
干预措施: Non-Investigational Antibody-Drug Conjugates (ADC) (Drug)
Cohort 2: Metastatic Triple Negative Breast Cancer (mTNBC) participants enrolled before ADC1
Participants with histologically documented metastatic TNBC with a plan to start an FDA-approved ADC as their first ADC per usual care will be enrolled before beginning any ADC. Participants will have blood samples obtained during routine clinical visits during ADC1 and ADC2, if applicable.
干预措施: Medical Record Review (Other)
Cohort 3: HR+/HER2- mBC Participants enrolled before second line ADC (ADC2))
Participants with histologically documented HR+/HER2- MBC with plan to start an FDA-approved ADC as their second ADC per usual care (ADC1 should be an approved ADC administered per usual care or as monotherapy in a clinical trial; no prior experimental ADCs allowed). Clinical data from the first ADC must be available for retrospective review. Participants will have blood samples obtained during routine clinical visits during treatment of cancer with ADC2.
干预措施: Specimen collection (Procedure)
Cohort 3: HR+/HER2- mBC Participants enrolled before second line ADC (ADC2))
Participants with histologically documented HR+/HER2- MBC with plan to start an FDA-approved ADC as their second ADC per usual care (ADC1 should be an approved ADC administered per usual care or as monotherapy in a clinical trial; no prior experimental ADCs allowed). Clinical data from the first ADC must be available for retrospective review. Participants will have blood samples obtained during routine clinical visits during treatment of cancer with ADC2.
干预措施: Non-Investigational Antibody-Drug Conjugates (ADC) (Drug)
Cohort 3: HR+/HER2- mBC Participants enrolled before second line ADC (ADC2))
Participants with histologically documented HR+/HER2- MBC with plan to start an FDA-approved ADC as their second ADC per usual care (ADC1 should be an approved ADC administered per usual care or as monotherapy in a clinical trial; no prior experimental ADCs allowed). Clinical data from the first ADC must be available for retrospective review. Participants will have blood samples obtained during routine clinical visits during treatment of cancer with ADC2.
干预措施: Medical Record Review (Other)
Cohort 4: mTNBC participants enrolled before ADC2
Participants with histologically documented metastatic TNBC with plan to start an FDA-approved ADC as their second ADC per usual care (ADC1 should be an approved ADC administered per usual care or as monotherapy in a clinical trial; no prior experimental ADCs allowed). Clinical data from the first ADC must be available for retrospective review. Participants will have blood samples obtained during routine clinical visits during treatment of cancer with ADC2.
干预措施: Specimen collection (Procedure)
Cohort 4: mTNBC participants enrolled before ADC2
Participants with histologically documented metastatic TNBC with plan to start an FDA-approved ADC as their second ADC per usual care (ADC1 should be an approved ADC administered per usual care or as monotherapy in a clinical trial; no prior experimental ADCs allowed). Clinical data from the first ADC must be available for retrospective review. Participants will have blood samples obtained during routine clinical visits during treatment of cancer with ADC2.
干预措施: Non-Investigational Antibody-Drug Conjugates (ADC) (Drug)
Cohort 4: mTNBC participants enrolled before ADC2
Participants with histologically documented metastatic TNBC with plan to start an FDA-approved ADC as their second ADC per usual care (ADC1 should be an approved ADC administered per usual care or as monotherapy in a clinical trial; no prior experimental ADCs allowed). Clinical data from the first ADC must be available for retrospective review. Participants will have blood samples obtained during routine clinical visits during treatment of cancer with ADC2.
干预措施: Medical Record Review (Other)
结局指标
主要结局
Real-world progression free survival (rwPFS) of first line ADC (ADC1)
时间窗: Up to 5 years
rwPFS is defined as the amount of time that elapses between the initiation of ADC1 therapy until the patient experiences disease progression, initiates subsequent anti-cancer therapy, completes study participation, or experiences death from any cause (whichever comes first).
rwPFS of second line ADC (ADC2)
时间窗: Up to 5 years
rwPFS is defined as the amount of time that elapses between the initiation of ADC2 therapy following a previous line of ADC (ADC1) until the participant experiences disease progression, initiates subsequent anti-cancer therapy, completes study participation, or experiences death from any cause (whichever comes first).
次要结局
- Median Duration of Response (DOR)(Up to 5 years)
- Best Overall Response (BOR)(Up to 5 years)
- Overall Response Rate (ORR)(Up to 5 years)
- Disease Control Rate (DCR)(Up to 5 years)
- Median Real-World Overall Survival Rate (rwOS)(Up to 5 years)
- Frequency of usual ADC-related Adverse Events (AEs)(Up to 5 years)