Clinical trialNCT06018337Active, not recruitingPhase 3Interventional

A Study of DB-1303/BNT323 vs Investigator's Choice Chemotherapy in HER2-Low, Hormone Receptor Positive Metastatic Breast Cancer (DYNASTY-Breast02)

SponsorDualityBio Inc.Enrollment541Metastatic Breast Cancer

View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

The goal of this clinical trial is to assess the efficacy of DB-1303/BNT323 compared with investigator's choice chemotherapy in terms of progression-free survival (PFS) by blinded independent central review (BICR) in the HR+, HER2-low (immunohistochemistry \[IHC\]2+/in situ hybridization \[ISH\]- and IHC 1+) population.

clinicaltrials.gov ↗

Investigators

The overall officials registered on this study. Names that resolve to a findmyKOL profile link to it; the rest are shown as registered.

Joyce O'Shaughnessy, PHD
Texas Oncology - Baylor Charles A. Sammons Cancer center
Principal InvestigatorKOL profile →
clinicaltrials.gov ↗

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

258 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

Argentina

Research Site 5411-0
Bahía Blanca, Buenos Aires, Argentina
Research Site 5414-0
CABA, Buenos Aires, Argentina
Research Site 5405-0
La Plata, Buenos Aires, Argentina
Research Site 5413-0
Mar del Plata, Buenos Aires, Argentina
Research Site 5408-0
Quilmes, Buenos Aires, Argentina
Research Site 5403-0
CABA, Ciudad Autonoma Buenos Aires, Argentina
Research Site 5407-0
Ciudad Autonoma Buenos Aires, Ciudad Autonoma Buenos Aires, Argentina
Research Site 5409-0
Ciudad Autonoma Buenos Aires, Ciudad Autonoma Buenos Aires, Argentina
Research Site 5412-0
Córdoba, Córdoba Province, Argentina
Research Site 5402-0
Viedma, Río Negro Province, Argentina
Research Site 5401-0
Rosario, Santa Fe Province, Argentina
Research Site 5406-0
Rosario, Santa Fe Province, Argentina
Research Site 5404-0
San Miguel de Tucumán, Tucumán Province, Argentina

Australia

Research Site 6108-0
Camperdown, New South Wales, Australia
Research Site 6116-0
Kingswood, New South Wales, Australia
Research Site 6109-0
Liverpool, New South Wales, Australia
Research Site 6102-0
Sydney, New South Wales, Australia
Research Site 6106-0
Birtinya, Queensland, Australia
Research Site 6101-0
South Brisbane, Queensland, Australia
Research Site 6107-0
Southport, Queensland, Australia
Research Site 6104-0
Townsville, Queensland, Australia
Research Site 6110-0
Adelaide, South Australia, Australia
Research Site 6103-0
Bendigo, Victoria, Australia
Research Site 6105-0
St Albans, Victoria, Australia
Research Site 6113-0
Traralgon, Victoria, Australia
Research Site 6114-0
Perth, Western Australia, Australia

Belgium

Research Site 3201-0
Brussels, Brussels Capital, Belgium
Research Site 3204-0
Ghent, Gent, Belgium
Research Site 3205-0
Jette, Jette, Belgium
Research Site 3203-0
Leuven, Leuven, Belgium
Research Site 3207-0
Liège, Liege, Belgium
Research Site 3202-0
Roeselare, Roeselare, Belgium

Canada

Research Site 1007-0
Winnipeg, Manitoba, Canada
Research Site 1003-0
Brampton, Ontario, Canada
Research Site 1001-0
Toronto, Ontario, Canada
Research Site 1004-0
Montreal, Quebec, Canada
Research Site 1005-0
Montreal, Quebec, Canada
Research Site 1006-0
Montreal, Quebec, Canada
Research Site 1002-0
Sherbrooke, Quebec, Canada

China

Research Site 8614-0
Hefei, Anhui, China

218 more sites on the registry record.ClinicalTrials.gov ↗

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

Capecitabine →DB-1303/BNT323Paclitaxel →

Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start: 18 Jan 2024
Primary completion: 30 Jun 2026
Completion: 31 Aug 2028
Last update posted: 2 Jun 2026
Registered enrollment: 541
Registry id: NCT06018337

clinicaltrials.gov ↗

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.