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Prospective Registry of ADC as First- and Second-line Treatment for Breast Cancer

ENCORE: Multicenter ProspectivE Registry of Sequential ANtibody Drug COnjugates (ADCs) in HER2 Negative Metastatic BREast Cancer (MBC)

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 2 years

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "After the last dose of ADC2, participants will continue to be followed for survival data collection via chart review every 12 weeks for up to 2 years."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tracks adults with breast cancer that has spread to other parts of the body who are starting their first or second antibody-drug conjugate (ADC). ADCs are drugs that use antibodies to carry cancer-killing medicine to cells. The study collects information about FDA-approved ADCs given as part of usual care, rather than assigning treatment.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be age 18 or older and able to give written consent to join.
  • The study doctor expects you to live at least 3 months.
  • Be willing to give a stored tissue sample and blood samples for research. Each blood draw is about 20 milliliters, or 4 teaspoons.
  • Have breast cancer confirmed by a tissue test that has spread to other parts of the body.
  • Have hormone receptor-positive, HER2-negative cancer, which can use hormones to grow but does not have high HER2 levels; or triple-negative cancer, which lacks all three of these markers.
  • Plan to start an FDA-approved ADC as your first or second ADC as part of usual care.
  • If starting your second ADC, your first must have been an approved ADC given through usual care or alone in a clinical trial. Records from that treatment must be available for review.
  • Your cancer does not need to be measurable on scans.

Who can't join

  • You previously received an experimental ADC for breast cancer that had spread.
  • You receive an experimental treatment after starting your first ADC. Joining a trial of an experimental treatment after that point means you must leave this study.
  • You are currently in a clinical trial involving an ADC.
  • You have a medical reason that makes research blood draws unsafe.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: 1. Male or female patients aged 18 years or greater with ability to provide written informed consent for this prospective registry study. 2. Estimated life expectancy of at least at 3 months per investigator assessment. 3. Willingness to provide an archival tissue sample and blood samples (20cc research blood collection at several timepoints) for research purposes. 4. 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. Exclusion Criteria: 1. 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 ADC1. If a patient enrolls on a clinical trial of an experimental therapy after ADC1, they will be taken off study. 2. Current participation in a clinical trial with an ADC. 3. Contraindication to research phlebotomy to collect \~20cc blood at each research blood draw timepoint.

Study sites (3)

CA

NC

NY