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DNA-Guided Second Line Adjuvant Therapy For High Residual Risk, Stage II-III, Hormone Receptor Positive, HER2 Negative Breast Cancer

Active: Yes
Cancer Type: Breast Cancer
Unknown Primary
NCT ID: NCT04567420
Trial Phases: Phase II Protocol IDs: DARE (primary)
Eligibility: 0 Years and older, Male and Female Study Type: Treatment
Study Sponsor: Criterium, Inc.
NCI Full Details:


A randomized, Phase II trial of circulating tumor DNA-guided second line Adjuvant therapy for
high Residual risk, stage II-III, Estrogen Receptor positive, HER-2 negative breast cancer


Surveillance population and ctDNA screening (up to 1000 patients): Clinically high risk,
stage II-III, ER positive, HER2-, breast cancer patients who are currently receiving adjuvant
endocrine therapy with an aromatase inhibitor or tamoxifen are eligible for ctDNA screening
if they meet any one of the following criteria for high risk for recurrence: (i) predicted
risk of distant recurrence or death equal to or greater than 15% calculated by PREDICT, RSPC,
or CTS5 (for late recurrence), (ii) four or more positive axillary lymph nodes or ipsilateral
supraclavicular involvement regardless of tumor size, (iii) primary tumor equal to or greater
than 5 centimeters regardless of nodal status, (iv) patients with 1-3 positive nodes,
regardless of tumor size are eligible if at least one of the following is also true: grade 3
histology, greater than or equal to 3 cm tumor size, high molecular risk score (i.e. Oncotype
Dx Recurrence score(RS) > 26, MammaPrint high risk, EndoPredict > 4, Prosigna score > 60).

In order to start ctDNA surveillance, patients must be currently receiving endocrine therapy
and have completed at least 6 months, but no more than 7 years and with at least 3 more years
of planned adjuvant endocrine therapy of treatment without distant recurrence. Prior adjuvant
CDK4/6 therapy is allowed, but at least 12 months must have elapsed since completing CDK4/6
therapy and enrolling into ctDNA surveillance on this study. However, participants in the
PENELOPE and PALLAS clinical trials are not eligible.

For screening, patients will undergo Signatera testing during routine follow up clinic
visits. The current ASCO/NCCN breast cancer practice guidelines recommend follow up visits
every 4 to 6 months at the treating physician's discretion. The investigators anticipate that
screening positivity rates will be the highest in patients between years 1-5 after initial
diagnosis, based on the annual hazard rates of recurrence in ER positive breast cancer.
However, since up to 50% of all recurrences occur after 5 years of follow-up, the
investigators allow starting ctDNA screening up to 7 years after starting adjuvant endocrine
therapy if a patient meets criteria for high risk.
**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts... Click here to learn more about clinical trials.