CLINICAL TRIALS

RECAST DCIS

Since the introduction of population-based screening, diagnoses of ductal carcinoma in situ (DCIS) have increased five-fold. It now accounts for up to 20-25% of all newly diagnosed breast cancers in the US. The current standard of care for women diagnosed with DCIS is surgery (lumpectomy) and/or radiation therapy. However, not all DCIS lesions are the same.

Most DCIS lesions detected by screening will never become clinically important — it is estimated that only 20-40% will progress to become invasive cancer. This means that 60-80% of women diagnosed with DCIS may be overtreated.

The RECAST DCIS Trial

RECAST DCIS is a platform trial for women that uses active surveillance as an alternative to immediate surgery, to monitor women receiving risk-reducing endocrine therapies, only escalating to surgery only in the event of early signals of progression. It aims to develop newer, effective modern endocrine therapies that have fewer side effects than current options, while validating non-invasive MRI-based tools that can assess the risk of progression. Importantly, the development of improved endocrine therapies also has broad application in the prevention of breast cancer in women at high-risk.

A critical element of the RECAST trial is the use of MRI to assess response to endocrine risk-reducing therapy using imaging features (lesion conspicuity, presence of mass or non-mass enhancement [NME], baseline background parenchymal enhancement [BPE] and change in BPE and lesion). These features can inform DCIS management and identify patients suitable for active surveillance and endocrine therapy as primary treatment.

Features

A Win-Win Approach

RECAST aims to reduce unnecessary surgery for DCIS, while at the same time identifying improved breast cancer risk-reduction treatments.

Imaging Biomarkers

Features on non-invasive MRI images, such as background parenchymal enhancement, provide critical information about the risk of progression of DCIS.

Personalized Medicine

RECAST uses a patient's response to endocrine risk-reduction therapy as an indicator of whether active surveillance is appropriate for them.

Surgery Option

For patients whose DCIS does not respond to risk-reduction treatment and show a high risk of progression proceed to surgery.

Toxicity Endpoint

Side effects are a major reason adoption of endocrine risk-reduction is shunned by patients. Identifying more effective and/or less toxic treatments is key to reducing breast cancer incidence in general.

Platform Design

Multiple agents can be efficiently, independently evaluated in parallel. Using a master protocol means agents can enter and leave the trial with a simple amendment.

Study Design

Description of figure: A platform trial design in which participants are randomized to one of several investigational agents or a control therapy (tamoxifen or aromatase inhibitor). Participants are assessed by MRI (along with blood draw and saliva test) after three months and six months. Following each MRI, if the assessment indicates a low risk of progression, participants are given the option of continuing the medication. If it indicates a high risk of progression, participants are recommended to undergo surgical resection of the lesion.

Who is it for

Women aged 18+ years of age with a previous diagnosis of hormone receptor-positive DCIS (at least 50% ER or PR; biopsy will have been performed previously at diagnosis) with or without microinvasion.

Clinical Sites

RECAST DCIS is open at sites including Berkeley, UCSF, John Muir, COH Duarte, COH S. Pasadena, COH Irvine, UCLA, Huntsman, Maple Grove CC, Henepin County MC, U Minnesota, Frauenshuh CC, Health Partners, U Chicago, Vanderbilt, Mt Sinai Union Sq, Mt Sinai West, Mt Sinai Chelsea, Icahn SOM, Englewood MC, Duke, Atrium/Wake Forest, Emory, and Moffitt.

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