Havah Therapeutics Announces SABCS 2026 Poster Acceptance as RECAST Tests Alternatives to Surgery for DCIS
The study builds on encouraging early observations. In pooled RECAST findings reported at SABCS 2025, 22 of 25 participants with at least six months of follow-up remained on active surveillance (88%). Reported adverse events were all grade 1 or 2, with no serious adverse events at that cutoff. These previously reported results span the treatment arms and are not HAV-088-specific outcomes. Imaging progression and a case of invasive disease identified at surgery were also reported, reinforcing the importance of careful selection and continued monitoring.
“RECAST is testing whether HAV-088, an investigational androgen-based therapy, can help women with DCIS control their disease and remain on active surveillance,” said Laura Esserman, MD, MBA, Director of the UCSF Breast Care Center and principal investigator of RECAST DCIS. “Women urgently need well-tolerated treatment options beyond tamoxifen and aromatase inhibitors. This is a promising agent that is well tolerated and doesn’t require taking a pill every day. It’s an exciting new approach to DCIS control and we look forward to the final outcomes.”
“A DCIS diagnosis should come with more options,” said Matthew Brewer, Chief Executive Officer of Havah Therapeutics. “COMET’s two-year findings challenge the assumption that surgery must always be the immediate first step for women with DCIS. That creates an important opportunity to develop new therapies that can help women control their disease and remain on active surveillance. Our ambition for HAV-088 is to expand those treatment choices, and RECAST is putting that ambition to the test.”
HAV-088 is an investigational subcutaneous implant combining testosterone with low-dose anastrozole, designed to provide approximately three months of therapy. Its approach centers on hormone metabolism within breast tissue: testosterone supplies the precursor for dihydrotestosterone (DHT), a potent androgen, while low-dose anastrozole is intended to limit competing conversion to estrogen. This strategy aims to strengthen local androgen receptor signaling without relying on systemic estrogen depletion. Preclinical research has shown that androgen receptor activation can suppress estrogen-driven growth in estrogen receptor-positive breast cancer models.
“The opportunity is to engage the breast’s own androgen signaling to restrain estrogen-driven growth,” said Professor Stephen Birrell, MD, PhD, Founder and Chief Medical Officer of Havah Therapeutics. “HAV-088 is designed to translate that biology into a practical, long-acting treatment. RECAST is testing whether that approach can deliver meaningful benefit for women with DCIS.”
DCIS involves abnormal cells confined to the milk ducts and carries a variable risk of progression to invasive disease. Surgery remains standard treatment. RECAST uses treatment response and imaging to help distinguish women suitable for continued active surveillance from those who should proceed to surgery. Longer follow-up and treatment-specific analyses are needed to establish efficacy and the safety of long-term nonoperative management.
Presentation details
Title: RECAST: A Randomized Phase II Platform Trial Evaluating Novel Endocrine Therapies to Facilitate and Safely Select Patients with Hormone Receptor–Positive Ductal Carcinoma In Situ for Active Surveillance
Format: Trials-in-progress poster
Abstract and presentation numbers: 2244 / P2-1-16
Date and time: Wednesday, December 9, 2026, 5:00–6:30 p.m. Central Time
Location: Exhibit Hall, San Antonio Breast Cancer Symposium
About RECAST DCIS
RECAST DCIS (NCT06075953) is a multicenter, randomized Phase 2 platform trial sponsored and operated by Quantum Leap Healthcare Collaborative. It evaluates standard endocrine therapy and three investigational strategies: HAV-088, elacestrant and (Z)-endoxifen. Serial MRI helps assess treatment response and suitability for continued active surveillance; patients with higher-risk findings are recommended for surgery. The study also assesses safety, imaging biomarkers and patient-reported outcomes.
About Havah Therapeutics
HAV-088 combines testosterone and low-dose anastrozole in an investigational implant designed to deliver approximately three months of therapy. The approach aims to strengthen local androgen signaling: testosterone supplies a precursor for dihydrotestosterone, while low-dose anastrozole is intended to limit competing conversion to estrogen.
HAV-088 is being evaluated in RECAST DCIS (NCT06075953), a randomized Phase 2 platform sponsored by Quantum Leap Healthcare Collaborative. The trial tests whether endocrine therapy and MRI monitoring can help women with hormone receptor-positive ductal carcinoma in situ remain suitable for active surveillance. Surgery remains standard treatment. HAV-088 is not FDA-approved, and its safety and efficacy have not been established.
Data source
Hewitt KC et al. Initial results from RECAST DCIS. SABCS 2025 abstract PS3-03-08. Clinical Cancer Research. 2026;32(4 Supplement). doi:10.1158/1557-3265.SABCS25-PS3-03-08. Mechanistic rationale: Hickey TE et al. Nature Medicine. 2021;27:310–320. doi:10.1038/s41591-020-01168-7.
Matthew Brewer
Havah Therapeutics, Inc
mb@havahtx.com
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