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Chemotherapy

DB-1303 for Breast Cancer

Phase 3

Recruiting

Research Sponsored by DualityBio Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Pathologically documented breast cancer that is advanced or metastatic, has HER2-low expression (IHC 1+ or IHC 2+/ISH-), was never previously reported as HER2-positive (IHC 3+ or ISH+), and is documented as HR+ (ER and/or PgR positive [ER or PgR ≥1%])

Must have an adequate tumor tissue sample available for assessment of HER2 by central laboratory, preferably in formalin fixation and paraffin embedding (FFPE) blocks based on a mandatory FFPE tumor sample obtained at the time of metastatic disease or later

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to approximately 51 months

Awards & highlights

Study Summary

This trial will compare the effectiveness of two treatments for HR+/HER2- breast cancer in terms of progression-free survival.

Who is the study for?

Adults with advanced or metastatic breast cancer that is HR+, HER2-low, and have not had chemotherapy for this stage of the disease. They must be in good physical condition (ECOG 0 or 1), have a life expectancy over 12 weeks, and agree to use effective contraception. Those who've progressed on endocrine therapy plus CDK4/6 inhibitor or two lines of endocrine therapy are eligible.Check my eligibility

What is being tested?

The trial tests DB-1303 against standard chemotherapies like Paclitaxel, Nab-paclitaxel, Capecitabine chosen by the investigator. It measures how long patients live without their cancer getting worse using blinded independent review.See study design

What are the potential side effects?

Potential side effects include those common to chemotherapy such as nausea, fatigue, hair loss, low blood cell counts leading to increased infection risk and bleeding problems. Specific side effects of DB-1303 are not listed but may be similar to other drugs in its class.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My breast cancer is advanced, not previously HER2-positive, but has low HER2 and is hormone receptor positive.

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I have a tumor tissue sample available for HER2 testing.

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I am fully active or can carry out light work.

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My cancer worsened within 6 months on specific breast cancer treatments and I'm considered suitable for chemotherapy.

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My doctor expects me to live for at least 12 more weeks.

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I have a tumor that can be measured or bone disease assessable by scans.

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I am a man who can father children and will use a condom with spermicide during the study.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to approximately 51 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to approximately 51 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 51 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Progression-free survival (PFS) in the HR+, HER2-low population

Secondary outcome measures

Duration of response (DoR) in the HR+, HER2-low population

European Quality of Life Five Dimension Five Level Scale (EQ-5D-5L)

Objective response rate (ORR) in the HR+, HER2-low population

+7 more

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: DB-1303/BNT323Experimental Treatment1 Intervention

Enrolled Subjects will be randomized to receive a 8 mg/kg IV dose of DB-1303/BNT323 on Day 1 of each cycle Q3W

Group II: investigator's choice single agent chemotherapyActive Control3 Interventions

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.

0 / 7Eligibility criteria met

Find a Location

Who is running the clinical trial?

BioNTech SEIndustry Sponsor

64 Previous Clinical Trials

107,166 Total Patients Enrolled

DualityBio Inc.Lead Sponsor

7 Previous Clinical Trials

2,385 Total Patients Enrolled

Raymond ZhaoStudy DirectorDualityBio Inc.

3 Previous Clinical Trials

654 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has the Food and Drug Administration approved DB-1303 for distribution?

"The safety of DB-1303 was ranked a 3 in the Power evaluation, as it is currently undergoing Phase 3 trials. This indicates that there are some reports attesting to its efficacy and multiple records validating its harmlessness."

Answered by AI

Are researchers currently seeking participants for this experiment?

"According to the research posted on clinicaltrials.gov, this particular trial is no longer looking for patients - it was initially listed on November 1st 2023 and amended eight weeks ago. However, there are a total of 2421 other medical studies presently recruiting participants at this time."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2024. "A Study of DB-1303/BNT323 vs Investigator's Choice Chemotherapy in HER2-Low, Hormone Receptor Positive Metastatic Breast Cancer (DYNASTY-Breast02)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06018337.