A Study of DB-1303/BNT323 vs Investigator's Choice Chemotherapy in HER2-Low, Hormone Receptor Positive Metastatic Breast Cancer (DYNASTY-Breast02)
NCT ID: NCT06018337
Last Updated: 2025-07-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
532 participants
INTERVENTIONAL
2024-01-18
2028-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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DB-1303/BNT323
Enrolled Subjects will be randomized to receive a 8 mg/kg IV dose of DB-1303/BNT323 on Day 1 of each cycle Q3W
DB-1303/BNT323
IV
investigator's choice single agent chemotherapy
Enrolled Subjects will be randomized to receive investigator's choice single agent chemotherapy (capecitabine:1000 or 1250 mg/m2, Oral, Twice daily orally for 2 weeks followed by a 1-week rest period in 3-week cycles; paclitaxel：80 mg/m2， IV, Every week (QW) in 3-week cycles; or nab-paclitaxel: 100 mg/m2, IV, Every week (QW) for 3 weeks followed by a one-week rest period in 4-week cycles) until RECIST 1.1 defined disease progression (PD), unless there is unacceptable toxicity, withdrawal of consent, or another criterion for discontinuation is met.
Capecitabine
Oral
Paclitaxel
IV
Nab-paclitaxel
IV
Interventions
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DB-1303/BNT323
IV
Capecitabine
Oral
Paclitaxel
IV
Nab-paclitaxel
IV
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
ALL
No
Sponsors
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BioNTech SE
INDUSTRY
DualityBio Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Joyce O'Shaughnessy, PHD
Role: PRINCIPAL_INVESTIGATOR
Texas Oncology - Baylor Charles A. Sammons Cancer center
Locations
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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 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 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 1101-0
Dallas, Texas, United States
Research Site 1116-0
Denison, Texas, United States
Research Site 1115-0
Houston, Texas, United States
Research Site 1117-0
San Antonio, 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 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
Baoding, Hebei, 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-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 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
Napoli, , 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 9010-0
Izmir, , Turkey (Türkiye)
Research Site 9007-0
Samsun, , Turkey (Türkiye)
Research Site 4404-0
Truro, Cornwall, United Kingdom
Research Site 4408-0
London, Greater London, United Kingdom
Research Site 4411-0
London, Greater London, United Kingdom
Research Site 4406-0
London, Greater London, United Kingdom
Research Site 4416-0
London, Greater London, United Kingdom
Research Site 4409-0
London, Greater London, United Kingdom
Research Site 4402-0
Manchester, Greater Manchester, United Kingdom
Research Site 4415-0
Maidstone, Kent, United Kingdom
Research Site 4414-0
Bath, Somerset, United Kingdom
Research Site 4410-0
Cardiff, South Glamorgan, United Kingdom
Research Site 4405-0
Glasgow, Strathclyde, United Kingdom
Research Site 4416-A
Sutton, Surrey, United Kingdom
Research Site 4407-0
Leeds, West Yorkshire, United Kingdom
Research Site 4403-0
Middlesex, , United Kingdom
Research Site 4401-0
Nottingham, , United Kingdom
Countries
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Central Contacts
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Other Identifiers
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CTR20233708
Identifier Type: OTHER
Identifier Source: secondary_id
DB-1303-O-3002
Identifier Type: -
Identifier Source: org_study_id
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