BNT327 + Chemotherapy for Breast Cancer

Recruiting at 63 trial locations

Overseen By BioNTech clinical trials patient information

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: BioNTech SE

Must not be taking: Corticosteroids, Antibiotics, Immunosuppressants, others

Disqualifiers: Pregnancy, Autoimmune disease, Heart conditions, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: up to 2 years

70 Participants Needed

Trial Summary

What is the purpose of this trial?

This study is a Phase II, multi-site, randomized, open-label clinical study to evaluate the safety, efficacy, and pharmacokinetics (PK) of BNT327 at two dose levels in combination with chemotherapeutic agents in the first- and second-line treatment of participants with locally advanced/metastatic triple-negative breast cancer (mTNBC).

Do I need to stop my current medications to join the trial?

The trial protocol does not specify if you need to stop taking your current medications. However, it mentions that you should not have received certain treatments like systemic anticancer therapy, immunosuppressive drugs, or live vaccines within a few weeks before starting the study. It's best to discuss your current medications with the study team to see if they might affect your eligibility.

What data supports the effectiveness of the drug BNT327 + Chemotherapy for Breast Cancer?

Research shows that combining different chemotherapy drugs, like paclitaxel and vinorelbine, can be effective in treating metastatic breast cancer, especially in patients who have been treated with other drugs before. This suggests that combining BNT327 with chemotherapy might also be effective, although specific data on BNT327 is not available. ^{1 2 3 4 5}

Research Team

BioNTech Responsible Person

Principal Investigator

BioNTech SE

Eligibility Criteria

This trial is for adults with advanced triple-negative breast cancer who haven't had systemic therapy for metastatic disease. They must have completed any prior treatment over 6 months ago, provide a recent tumor sample, and have at least one measurable lesion. Those with certain previous treatments or only one targetable lesion may not qualify.

Inclusion Criteria

Have given informed consent by signing and dating the informed consent form before initiation of any study-specific procedures

Have a minimum life expectancy of >3 months

I have given a tissue sample for testing during the screening.

Exclusion Criteria

Are pregnant or breastfeeding or are planning pregnancy or planning to father children during the study or within 60 days or five half-lives after the last dose of IMP

I have not had major surgery, significant injury, or invasive dental work in the last 28 days.

Have a medical, psychological, or social condition which, in the opinion of the investigator, could compromise their wellbeing if they participate in the study

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive BNT327 at two dose levels in combination with chemotherapeutic agents until disease progression, intolerable toxicity, participant withdrawal, death, study termination, or up to 2 years

up to 2 years

Follow-up

Participants are monitored for safety and effectiveness after treatment

up to 24 months after completion of study treatment

Treatment Details

Interventions

• BNT327

Trial Overview The study tests BNT327's safety and effectiveness in two doses combined with chemotherapy (Taxane A/B, Antimetabolite, Alkylating agent) for first- or second-line treatment of metastatic breast cancer. It's an open-label Phase II trial assessing how the body processes the drug too.

Participant Groups

Group I: Cohort 2 Arm 3 - BNT327 Equivalent Q3W dose + Eribulin Experimental Treatment 2 Interventions

Group II: Cohort 2 Arm 2 - BNT327 Equivalent Q3W dose + Gemcitabine + Carboplatin Experimental Treatment 3 Interventions

Group III: Cohort 2 Arm 1 - BNT327 Optimized dose + Paclitaxel Experimental Treatment 2 Interventions

Group IV: Cohort 1 Arm 2 - BNT327 DL2 + Nab-paclitaxel Experimental Treatment 2 Interventions

Group V: Cohort 1 Arm 1 - BNT327 DL1 + Nab-paclitaxel Experimental Treatment 2 Interventions

Who Is Running the Clinical Trial?

BioNTech SE

Lead Sponsor

Trials

84

Recruited

120,000+

Prof. Dr. Ugur Sahin

BioNTech SE

Chief Executive Officer since 2008

MD from University of Cologne

Prof. Özlem Türeci

BioNTech SE

Chief Medical Officer since 2018

MD from Saarland University

Findings from Research

In a study of 75 patients with operable breast cancer, the combination of capecitabine and vinorelbine (CV-D) showed comparable pathologic complete response (pCR) rates to the standard regimen of adriamycin and cyclophosphamide followed by docetaxel (AC-D), with pCR rates of 11% for CV-D and 15% for AC-D.

CV-D was associated with fewer severe side effects like grade 3-4 neutropenia and vomiting compared to AC-D, although it did lead to more manageable side effects such as diarrhea and hand-foot syndrome, indicating it may be a safer alternative for some patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Randomized Phase II Trial of Capecitabine Plus Vinorelbine Followed by Docetaxel Versus Adriamycin Plus Cyclophosphamide Followed by Docetaxel as Neoadjuvant Chemotherapy for Breast Cancer. Yoo, C., Kim, SB., Ahn, JH., et al.[2018]

Chemotherapy, particularly with taxoids like docetaxel and paclitaxel, shows significant activity against metastatic breast cancer, but overall survival rates remain disappointing, indicating a need for better treatment options.

Recent trials suggest that high-dose chemotherapy may lead to higher complete response rates and potential survival benefits compared to traditional dosing, highlighting the importance of ongoing research into new treatment strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Optimising treatment outcomes: a review of current management strategies in first-line chemotherapy of metastatic breast cancer. Crown, J.[2019]

In a phase II trial involving 56 metastatic breast cancer patients previously treated with anthracyclines, the combination of paclitaxel and vinorelbine showed a response rate of 46%, indicating significant anti-tumor activity.

The treatment was found to be safe and well-tolerated, with manageable side effects such as alopecia and myelosuppression, making it a convenient option for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Paclitaxel plus vinorelbine: an active regimen in metastatic breast cancer patients with prior anthracycline exposure. Martín, M., Lluch, A., Casado, A., et al.[2020]

Recent studies indicate that combination chemotherapy (doublet therapy) for metastatic breast cancer (MBC) can lead to higher response rates and longer progression-free survival compared to single-agent therapies, although the absolute benefits remain unclear due to lack of planned crossover in trials.

The future of MBC treatment may involve combining effective single-agent chemotherapies with novel biologic agents, such as the combination of paclitaxel and bevacizumab, which has shown promising results, but further research is needed to establish optimal treatment strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Considerations in treatment choice for metastatic breast cancer. Jones, SE.[2018]

Metastatic breast cancer (MBC) is a complex and varied disease, with treatment decisions heavily influenced by tumor characteristics and patient factors, particularly for hormone receptor-negative and refractory hormone-positive cases where cytotoxic chemotherapy remains the primary treatment.

Recent advancements in targeted therapies, when combined with traditional chemotherapy, are showing promise in improving outcomes for patients with MBC, especially those with limited options like triple-negative breast cancer, highlighting the importance of ongoing research to identify which patients will benefit most from these new regimens.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Beyond cytotoxic chemotherapy for the first-line treatment of HER2-negative, hormone-insensitive metastatic breast cancer: current status and future opportunities. Conlin, AK., Seidman, AD.[2014]

References

1. Korea (South) pubmed.ncbi.nlm.nih.gov

A Randomized Phase II Trial of Capecitabine Plus Vinorelbine Followed by Docetaxel Versus Adriamycin Plus Cyclophosphamide Followed by Docetaxel as Neoadjuvant Chemotherapy for Breast Cancer. [2018]

2. England pubmed.ncbi.nlm.nih.gov

Optimising treatment outcomes: a review of current management strategies in first-line chemotherapy of metastatic breast cancer. [2019]

3. England pubmed.ncbi.nlm.nih.gov

Paclitaxel plus vinorelbine: an active regimen in metastatic breast cancer patients with prior anthracycline exposure. [2020]

4. Japan pubmed.ncbi.nlm.nih.gov

Considerations in treatment choice for metastatic breast cancer. [2018]

5. United States pubmed.ncbi.nlm.nih.gov

Beyond cytotoxic chemotherapy for the first-line treatment of HER2-negative, hormone-insensitive metastatic breast cancer: current status and future opportunities. [2014]