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ACTIVE NOT RECRUITING

NCT06018337

PHASE3

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

Sponsor: DualityBio Inc.

View on ClinicalTrials.gov

Summary

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.

Official title: A Phase 3, Randomized, Multi-center, Open-Label Study of DB-1303 Versus Investigator's Choice Chemotherapy in Human Epidermal Growth Factor Receptor 2 (HER2)-Low, Hormone Receptor Positive (HR+) Metastatic Breast Cancer Patients Whose Disease Has Progressed on Endocrine Therapy (ET) (DYNASTY-Breast02)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

541

Start Date

2024-01-18

Completion Date

2028-07

Last Updated

2026-03-05

Healthy Volunteers

Conditions

Metastatic Breast Cancer

Interventions

DRUG

DB-1303/BNT323

DRUG

Capecitabine

Oral

DRUG

Paclitaxel

DRUG

Nab-paclitaxel

Inclusion Criteria: 1\. Male or female adults (defined as ≥ 18 years of age or acceptable age according to local regulations at the time of voluntarily signing of informed consent). 2\. Pathologically documented breast cancer that: 1. Is advanced or metastatic 2. Has HER2-low expression (IHC 1+ or IHC 2+/ISH-) as determined by the central laboratory result. 3. Was never previously reported as HER2-positive (IHC 3+ or ISH+) as per American Society of Clinical Oncology/College of American Pathologists (ASCO/CAP) guidelines. 4. Is documented as HR+ (either estrogen receptor \[ER\] and/or progesterone receptor \[PgR\] positive \[ER or PgR ≥1%\]) per ASCO/CAP guidelines (Allison et al 2020). 3\. Must have an adequate tumor tissue sample available for assessment of HER2 by central laboratory, in formalin fixation and paraffin embedding (FFPE) blocks based on a mandatory FFPE tumor sample preferably obtained at the time of metastatic disease or later; 4\. Eastern Cooperative Oncology Group performance status of 0 or 1. 5\. Must have had either: 1. Disease progression on endocrine therapy + CDK4/6 inhibitor within 6 months of starting first line treatment for metastatic disease and considered appropriate for chemotherapy as the next treatment by the investigator, OR 2. Disease progression on at least 2 previous lines of ET with or without a targeted therapy (such as CDK4/6, mammalian target of rapamycin \[mTOR\] or phosphoinositide 3-kinase \[PI3-K\] inhibitors) administered for the treatment of metastatic disease. 6\. No prior chemotherapy for advanced or metastatic breast cancer. Subjects who have received chemotherapy in the neo-adjuvant or adjuvant setting are eligible, as long as they have had a disease-free interval (defined as completion of systemic chemotherapy to diagnosis of advanced or metastatic disease) of \>12 months. 7\. Life expectancy ≥12 weeks at screening. 8\. Subjects must have at least one measurable lesion as defined per RECIST v1.1 (For bone only disease, subjects with lytic or mixed lytic bone lesions that can be measured by CT or MRI are eligible; subjects with sclerotic/osteoblastic bone lesions are not eligible). 9\. Has LVEF ≥ 50% by either echocardiography (ECHO) or multiple-gated acquisition (MUGA) within 28 days before randomization. 10\. Adequate organ and bone marrow function within 14 days before randomization. 11\. Has adequate treatment washout period before randomization. 12\. Evidence of post-menopausal status or negative serum pregnancy test for females of childbearing potential who are sexually active with a non-sterilized male partner. For women of childbearing potential, a negative result for serum pregnancy test (test must have a sensitivity of at least 25 mIU/mL) must be available at the screening visit and urine beta-human chorionic gonadotropin (β-HCG) pregnancy test prior to each administration of study treatment. Women of childbearing potential are defined as those who are not surgically sterile (i.e., underwent bilateral salpingectomy, bilateral oophorectomy, or complete hysterectomy) or post-menopausal. 13\. Female subjects of childbearing potential who are sexually active with a non-sterilized male partner must use at least one highly effective method of contraception from the time of screening and must agree to continue using such precautions for 7 months after the last dose of study treatment. Not all methods of contraception are highly effective. Abstinence is acceptable only as true abstinence when this is in line with the preferred and usual lifestyle of the subject for the duration of the study treatment and the drug washout period (7 months). Periodic abstinence (e.g., calendar ovulation, symptothermal, post ovulation methods), the rhythm method, and the withdrawal method are not acceptable methods of contraception. Female subjects must not donate ova, or retrieve for their own use, from the time of screening and throughout the study treatment period, and for at least 7 months after the last dose of study treatment. They should refrain from breastfeeding throughout this time. Preservation of ova may be considered prior to randomization in this study. 14\. Non-sterilized male subjects who are sexually active with a female partner of childbearing potential must use a condom with spermicide from screening and throughout the duration of the study treatment and the washout period (4 months after the last dose of DB-1303, 6 months after the last dose of paclitaxel or nab-paclitaxel, and 3 months after the last dose of capecitabine). Abstinence is acceptable only as true abstinence when this is in line with the preferred and usual lifestyle of the subject for the duration of the study treatment and the drug washout period. Periodic abstinence (e.g., calendar ovulation, symptothermal, post ovulation methods), the rhythm method, and the withdrawal method are not acceptable methods of contraception. It is strongly recommended for the female partners of a male subject also use at least one highly effective method of contraception throughout this period. In addition, male subjects should refrain from fathering a child or donating sperm throughout the duration of the study and the washout period (4 months after the last dose of DB-1303, 6 months after the last dose of paclitaxel or nab paclitaxel, and 3 months after the last dose of capecitabine). Preservation of sperm should be considered prior to randomization in this study. 15\. Must be able and willing to comply with the protocol requirements and must sign and date the informed consent form prior to any screening evaluations. Exclusion Criteria: 1. Ineligible for all options in the investigator's choice chemotherapy arm. 2. Uncontrolled intercurrent illness, including but not limited to, ongoing or active infection, uncontrolled or significant cardiovascular disease, serious chronic gastrointestinal conditions associated with diarrhea, or psychiatric illness/social situations that would limit compliance with study requirement, substantially increase risk of incurring adverse events or compromise the ability of the subject to give written informed consent. 3. Clinically uncontrolled pleural effusion, ascites or pericardial effusion requiring repeated drainage, peritoneal shunt or cell-free concentrated ascites reinfusion therapy within 2 weeks prior to the randomization. 4. Uncontrolled or significant cardiovascular disease 5. Has a medical history of interstitial lung diseases (e.g., non-infectious interstitial pneumonia, pneumonitis, pulmonary fibrosis, and radiation pneumonitis which needs glucocorticoids and antibiotics) or current interstitial lung diseases or who are suspected to have these diseases by imaging at screening. 6. Has unresolved toxicities from previous anticancer therapy, defined as toxicities (other than alopecia) not yet resolved to Grade ≤ 1 or baseline or Grade ≤ 2 anemia. 7. Previous treatment with anti-HER2 therapy. 8. Prior treatment with antibody-drug conjugate that comprised an exatecan derivative that is a topoisomerase I inhibitor. 9. Prior randomization or treatment in a previous DB-1303/BNT323 study regardless of treatment assignment. 10. Has substance abuse or any other medical conditions such as psychological conditions, that may, in the opinion of the Investigator, interfere with the subject's participation in the clinical study or evaluation of the clinical study results. 11. Individuals who are dependent on the Sponsor, clinical site, or Investigator (e.g., is an employee of the Sponsor or the clinical trial site, a dependent of the Investigator, or any site staff member otherwise supervised by the Investigator). 12. Individuals who are committed to an institution by virtue of an order issued either by the judicial or the administrative authorities, in accordance with local regulations. NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

Locations (261)

Research Site 1141-0

Tucson, Arizona, United States

Research Site 1114-0

Fullerton, California, United States

Research Site 1107-0

Los Angeles, California, United States

Research Site 1118-0

Orange, California, United States

Research Site 1143-0

Sacramento, California, United States

Research Site 1132-0

Santa Barbara, California, United States

Research Site 1137-0

Aurora, Colorado, United States

Research Site 1129-0

Lone Tree, Colorado, United States

Research Site 1154-0

Jacksonville, Florida, United States

Research Site 1145-0

Miami, Florida, United States

Research Site 1150-0

Orange City, Florida, United States

Research Site 1125-0

Palm Bay, Florida, United States

Research Site 1155-0

Athens, Georgia, United States

Research Site 1110-0

Savannah, Georgia, United States

Research Site 1147-0

Chicago, Illinois, United States

Research Site 1124-0

Chicago Ridge, Illinois, United States

Research Site 1152-0

Fort Wayne, Indiana, United States

Research Site 1106-0

Merriam, Kansas, United States

Research Site 1104-0

Louisville, Kentucky, United States

Research Site 1122-0

Silver Spring, Maryland, United States

Research Site 8639-0

Silver Spring, Maryland, United States

Research Site 1109-0

Kansas City, Missouri, United States

Research Site 1158-0

Camden, New Jersey, United States

Research Site 1111-0

Florham Park, New Jersey, United States

Research Site 1157-0

Santa Fe, New Mexico, United States

Research Site 1148-0

Staten Island, New York, United States

Research Site 1105-0

Westbury, New York, United States

Research Site 1144-0

Chapel Hill, North Carolina, United States

Research Site 1138-0

Akron, Ohio, United States

Research Site 1160-0

Cincinnati, Ohio, United States

Research Site 1133-0

Eugene, Oregon, United States

Research Site 1126-0

Tigard, Oregon, United States

Research Site 1134-0

Broomall, Pennsylvania, United States

Research Site 1123-0

Horsham, Pennsylvania, United States

Research Site 1149-0

Knoxville, Tennessee, United States

Research Site 1102-0

Nashville, Tennessee, United States

Research Site 1159-0

Nashville, Tennessee, United States

Research Site 1101-0

Dallas, Texas, United States

Research Site 1116-0

Denison, Texas, United States

Research Site 1115-0

Houston, Texas, United States

Research Site 1199-0

Irving, Texas, United States

Research Site 1117-0

San Antonio, Texas, United States

Research Site USOR

Woodland, Texas, United States

Research Site 1130-0

Salt Lake City, Utah, United States

Research Site 1108-0

Fairfax, Virginia, United States

Research Site 1131-0

Fairfax, Virginia, United States

Research Site 1127-0

Roanoke, Virginia, United States

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 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

Research Site 5407-0

Ciudad Autonoma Buenos Aires, Argentina

Research Site 5409-0

Ciudad Autonoma Buenos Aires, Argentina

Research Site 5412-0

Córdoba, Argentina

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

Research Site 3201-0

Brussels, Belgium

Research Site 3204-0

Ghent, Belgium

Research Site 3205-0

Jette, Belgium

Research Site 3203-0

Leuven, Belgium

Research Site 3207-0

Liège, Belgium

Research Site 3202-0

Roeselare, Belgium

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

Research Site 8640-0

Hefei, Anhui, China

Research Site 8614-0

Hefei, Anhui, China

Research Site 8601-0

Beijing, Beijing Municipality, China

Research Site 8625-0

Beijing, Beijing Municipality, China

Research Site 8653-0

Beijing, Beijing Municipality, China

Research Site 8627-0

Chongqing, Chongqing Municipality, China

Research Site 8651-0

Fuzhou, Fujian, China

Research Site 8638-0

Xiamen, Fujian, China

Research Site 8630-0

Lanzhou, Gansu, China

Research Site 8604-0

Guangzhou, Guangdong, China

Research Site 8628-0

Guangzhou, Guangdong, China

Research Site 8621-0

Huizhou, Guangdong, China

Research Site 8622-0

Zhuhai, Guangdong, China

Research Site 8615-0

Nanning, Guangxi, China

Research Site 8629-0

Baoding, Hebei, China

Research Site 8645-0

Shijiazhuang, Hebei, China

Research Site 8619-0

Harbin, Heilongjiang, China

Research Site 8649-0

Anyang, Henan, China

Research Site 8609-0

Luoyang, Henan, China

Research Site 8648-0

Weihui, Henan, China

Research Site 8605-0

Zhengzhou, Henan, China

Research Site 8623-0

Zhengzhou, Henan, China

Research Site 8637-0

Wuhan, Hubei, China

Research Site 8608-0

Wuhan, Hubei, China

Research Site 8633-0

Xiangyang, Hubei, China

Research Site 8635-0

Changsha, Hunan, China

Research Site 8654-0

Yongzhou, Hunan, China

Research Site 8646-0

Huai'an, Jiangsu, China

Research Site 8607-0

Nanjing, Jiangsu, China

Research Site 8624-0

Xuzhou, Jiangsu, China

Research Site 8631-0

Nanchang, Jiangxi, China

Research Site 8612-0

Changchun, Jilin, China

Research Site 8618-0

Changchun, Jilin, China

Research Site 8644-0

Changchun, Jilin, China

Research Site 8636-0

Dalian, Liaoning, China

Research Site 8643-0

Shenyang, Liaoning, China

Research Site 8642-0

Shenyang, Liaoning, China

Research Site 8634-0

Jinan, Shandong, China

Research Site 8613-0

Jining, Shandong, China

Research Site 8610-0

Linyi, Shandong, China

Research Site 8650-0

Weihai, Shandong, China

Research Site 8603-0

Shanghai, Shanghai Municipality, China

Research Site 8602-0

Shanghai, Shanghai Municipality, China

Research Site 8611-0

Xi’an, Shanxi, China

Research Site 8606-0

Chengdu, Sichuan, China

Research Site 8626-0

Neijiang, Sichuan, China

Research Site 8647-0

Zigong, Sichuan, China

Research Site 8617-0

Tianjin, Tianjin Municipality, China

Research Site 8616-0

Ürümqi, Xinjiang, China

Research Site 8632-0

Kunming, Yunnan, China

Research Site 8652-0

Hangzhou, Zhejiang, China

Research Site 8620-0

Hangzhou, Zhejiang, China

Research Site 8641-0

Hangzhou, Zhejiang, China

Research Site 3311-0

Marseille, Bouches-du-Rhône, France

Research Site 3303-0

La Rochelle, Charente Maritime, France

Research Site 3312-0

Besançon, Doubs, France

Research Site 3308-0

Nîmes, Gard, France

Research Site 3314-0

Bordeaux, Gironde, France

Research Site 3305-0

Toulouse, Haute Garonne, France

Research Site 3309-0

Limoges, Haute Vienne, France

Research Site 3304-0

Montpellier, Herault, France

Research Site 3310-0

Saint-Herblain, Loire Atlantique, France

Research Site 3301-0

Angers, Maine Et Loire, France

Research Site 3315-0

Lille, Nord, France

Research Site 3306-0

Bayonne, Pyrenees Atlantiques, France

Research Site 3318-0

Pierre-Bénite, Rhone, France

Research Site 3313-0

Rouen, Seine Maritime, France

Research Site 3307-0

Avignon, Vaculuse, France

Research Site 3302-0

Créteil, Val De Marne, France

Research Site 3316-0

Paris, France

Research Site 4907-0

Erlangen, Bavaria, Germany

Research Site 4909-0

Wiesbaden, Hesse, Germany

Research Site 4904-0

Bottrop, North Rhine-Westphalia, Germany

Research Site 4902-0

Cologne, North Rhine-Westphalia, Germany

Research Site 4901-0

Witten, North Rhine-Westphalia, Germany

Research Site 4903-0

Dresden, Saxony, Germany

Research Site 4905-0

Berlin, Germany

Research Site 4906-0

Berlin, Germany

Research Site 8504-0

Hong Kong, Hong Kong

Research Site 8501-0

Hong Kong, Hong Kong

Research Site 8503-0

Hong Kong, Hong Kong

Research Site 8502-0

Hong Kong, Hong Kong

Research Site 8505-0

Hong Kong, Hong Kong

Research Site 3603-0

Budapest, Hungary

Research Site 3606-0

Győr, Hungary

Research Site 3604-0

Kecskemét, Hungary

Research Site 3602-0

Salgótarján, Hungary

Research Site 3607-0

Tatabánya, Hungary

Research Site 3605-0

Zalaegerszeg, Hungary

Research Site 9710-0

Ashdod, Israel

Research Site 9706-0

Haifa, Israel

Research Site 9708-0

Haifa, Israel

Research Site 9702-0

Jerusalem, Israel

Research Site 9707-0

Jerusalem, Israel

Research Site 9703-0

Kfar Saba, Israel

Research Site 9704-0

Petah Tikva, Israel

Research Site 9709-0

Ramat Gan, Israel

Research Site 9705-0

Rehovot, Israel

Research Site 9701-0

Tel Aviv, Israel

Research Site 3908-0

Bergamo, Italy

Research Site 3907-0

Brescia, Italy

Research Site 3901-0

Catania, Italy

Research Site 3903-0

Catanzaro, Italy

Research Site 3906-0

Milan, Italy

Research Site 3911-0

Milan, Italy

Research Site 3904-0

Milan, Italy

Research Site 3909-0

Naples, Italy

Research Site 3902-0

Pavia, Italy

Research Site 3905-0

Verona, Italy

Research Site 4804-0

Krakow, Poland

Research Site 4803-0

Lodz, Poland

Research Site 4801-0

Poznan, Poland

Research Site 4802-0

Rzeszów, Poland

Research Site 4807-0

Torun, Poland

Research Site 4805-0

Warsaw, Poland

Research Site 4809-0

Wroclaw, Poland

Research Site 8211-0

Wŏnju, Gangwon-do, South Korea

Research Site 8204-0

Seongnam-si, Gyeonggi-do, South Korea

Research Site 8201-0

Seoul, Gyeonggi-do, South Korea

Research Site 8202-0

Suwon, Gyeonggi-do, South Korea

Research Site 8208-0

Busan, South Korea

Research Site 8212-0

Cheonan, South Korea

Research Site 8209-0

Incheon, South Korea

Research Site 8207-0

Seoul, South Korea

Research Site 8213-0

Seoul, South Korea

Research Site 8206-0

Seoul, South Korea

Research Site 8210-0

Seoul, South Korea

Research Site 8203-0

Seoul, South Korea

Research Site 8205-0

Seoul, South Korea

Research Site 8214-0

Ulsan, South Korea

Research Site 3403-0

Sant Cugat del Vallès, Barcelona, Spain

Research Site 3409-0

Santiago de Compostela, La Coruña, Spain

Research Site 3406-0

Majadahonda, Madrid, Spain

Research Site 3411-0

Pozuelo de Alarcón, Madrid, Spain

Research Site 3405-0

Pamplona, Navarre, Spain

Research Site 3410-0

Barcelona, Spain

Research Site 3402-0

Barcelona, Spain

Research Site 3404-0

Barcelona, Spain

Research Site 3416-0

Madrid, Spain

Research Site 3407-0

Madrid, Spain

Research Site 3414-0

Madrid, Spain

Research Site 3401-0

Madrid, Spain

Research Site 3415-0

Málaga, Spain

Research Site 3418-0

Málaga, Spain

Research Site 3408-0

Seville, Spain

Research Site 3413-0

Seville, Spain

Research Site 3417-0

Seville, Spain

Research Site 3412-0

Valencia, Spain

Research Site 9001-0

Adana, Turkey (Türkiye)

Research Site 9002-0

Ankara, Turkey (Türkiye)

Research Site 9006-0

Ankara, Turkey (Türkiye)

Research Site 9003-0

Ankara, Turkey (Türkiye)

Research Site 9004-0

Ankara, Turkey (Türkiye)

Research Site 9009-0

Diyarbakır, Turkey (Türkiye)

Research Site 9008-0

Istanbul, Turkey (Türkiye)

Research Site 9012-0

Istanbul, Turkey (Türkiye)

Research Site 9010-0

Izmir, Turkey (Türkiye)

Research Site 9011-0

Mersin, Turkey (Türkiye)

Research Site 9007-0

Samsun, Turkey (Türkiye)

Research Site 4404-0

Truro, Cornwall, United Kingdom

Research Site 4408-0