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AzTrials

Locally Advanced Breast CancerPhase 2NCT06449222

Safety and Preliminary Effectiveness of BNT327, an Investigational Therapy for Breast Cancer, When Given in Combination With Chemotherapy

A Phase 2 study testing BNT327 Dose Level 1 (DL1), BNT327 Dose Level 1 (DL2) and Nab-placlitaxel in people with Locally Advanced Breast Cancer and Triple Negative Breast Cancer, run by BioNTech SE at 31 sites in 4 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

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… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
BNT327 Dose Level 1 (DL1), BNT327 Dose Level 1 (DL2) and Nab-placlitaxel
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
83 participants
Where
31 sitesin 4 countries
Study dates
26 Aug 2024to Jun 2029
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Have given informed consent by signing and dating an informed consent form before initiation of any study-specific procedures.
  • Male or female, aged ≥18 years at the time of giving informed consent.
  • Are willing and able to comply with scheduled visits, the treatment schedule, the planned study assessments (including participant completed diaries) and other requirements of the study. This includes that they are able to understand and follow study-related instructions.
  • Have confirmed locally recurrent inoperable or mTNBC as defined by the most recent American Society of Clinical Oncology (ASCO) / College of American Pathologists (CAP) guidelines. Note, participants initially diagnosed with hormone receptor-positive and/or HER2-positive breast cancer must have histological confirmation of TNBC in a tumor biopsy obtained from a local recurrence or distant metastasis site.
  • Systemic treatment naïve locally advanced/metastatic participants are eligible if:
  • They have received no prior systemic therapy in the locally advanced unresectable/metastatic setting including chemotherapy, immunotherapy, or investigational agents.
Show all 32Show fewer
  • They have completed treatment for Stage I-III breast cancer, if indicated, and ≥6 months has elapsed between the completion of treatment with curative intent (e.g., date of primary breast tumor surgery or date of last adjuvant chemotherapy administration, or date of last radiation therapy, whichever occurred last) and first documented local or distant disease recurrence. This also includes participants initially diagnosed with hormone receptor-positive and/or HER2-positive breast cancer prior to TNBC diagnosis.
  • Participants who received one prior systemic therapy in the locally advanced/metastatic setting are eligible if:
  • They have received one systemic chemotherapy in the metastatic setting and have progressed on first line therapy. Radiographic progression must have been documented. Radiographic progression is defined as unequivocal progression of existing tumor lesions or developing new tumor lesions as assessed by the investigator.
  • They have had a recurrence-free interval of ≥6 months if they have received treatment with curative intent in the past. A recurrence-free interval of ≥6 months is required for all participants (both first- and second-line treatment settings) who have received prior treatment for breast cancer with curative intent.
  • Have provided a tissue sample, archival or fresh, during the screening period (bone biopsies, fine needle aspiration biopsies, and samples from pleural or peritoneal fluid are not acceptable; participants with only one target lesion are not eligible to provide a biopsy). If an archival tumor sample is not available, the participant must undergo a fresh biopsy, if medically feasible to be eligible for the study.
  • Have at least one measurable lesion as the targeted lesion based on RECIST version 1.1. Lesions treated after prior local treatment (radiotherapy, ablation, interventional procedures) are generally not considered as target lesions. If the lesion with prior local treatment is the only targeted lesion, evidence-based radiology must be provided to demonstrate disease progression (the single bone metastasis or the single central nervous system metastasis should not be considered as a measurable lesion).
  • Eastern Cooperative Oncology Group performance status of 0 or 1.
  • Have a minimum life expectancy of >3 months.
  • Have adequate organ function, as defined below:
  • Hematology:
  • Absolute neutrophil count ≥1.5 × 10^9/L (without G-CSF support within two weeks prior to Cycle 1, Day 1).
  • Platelet count ≥100 × 10^9/L (without transfusion within 2 weeks prior to Cycle 1, Day 1).
  • Hemoglobin ≥90 g/L or 5.6 mmol/L. Note: Criterion must be met without packed red blood cell transfusion or without erythropoietin dependency within the prior 2 weeks before receiving the first dose of study treatment.
  • Liver function:
  • Total bilirubin ≤1.5 × upper limit of normal (ULN).
  • With Gilbert's syndrome total bilirubin <3 mg/dL and direct bilirubin ≤ULN. Note, Gilbert's syndrome must be documented appropriately as past medical history.
  • Participants without liver metastasis alanine aminotransferase and aspartate aminotransferase ≤2 × ULN.
  • Participants with liver metastasis alanine aminotransferase and aspartate aminotransferase ≤5 × ULN.
  • Albumin ≥3.0 g/dL.
  • Renal function: Creatinine clearance ≥50 mL/min. Cockcroft-Gault formula. Note, in participants who will be treated with gemcitabine plus carboplatin, creatinine clearance should be ≥60 mL/min.
  • Qualitative urine protein ≤1+. If qualitative urine protein ≥2+, a 24-hour urine protein quantitative test is required. If the 24-hour urine protein result is <1 g, the participant can be enrolled.
  • Coagulation function: International normalized ratio or prothrombin time and activated partial thromboplastin time ≤1.5 × ULN unless the participant is receiving anticoagulation therapy as long as prothrombin or activated partial thromboplastin is within therapeutic range of intended use of anticoagulant.
  • Are women of childbearing potential (WOCBP) who have a negative serum beta human chorionic gonadotropin pregnancy test. Women who are postmenopausal (defined as 12 months with no menses without an alternative medical cause) or permanently sterilized (verified by medical records) will not be considered WOCBP and therefore will not be required to undergo pregnancy testing.
  • Are WOCBP who agree to practice a highly effective form of contraception and to require the use of barrier contraception methods, starting at at the time of giving informed consent and continuously until 6 months after receiving the last study treatment.
  • Are men who are sterile or if they are potentially fertile (i.e., are not surgically [e.g., have had a vasectomy] or congenitally sterile) and sexually active with a partner of childbearing potential, who agree to use condoms and to ask their sexual partners to practice a highly effective form of contraception during the study, starting at the time of giving informed consent and continuously until 6 months after receiving the last dose of IMP.
  • Agree not to donate germ (ova, oocytes, sperm) for the purposes of assisted reproduction during study, starting at the time of giving informed consent and continuously until 6 months after receiving the last dose of IMP.

Who cannot join

  • Are pregnant or breastfeeding or are planning pregnancy or planning to father children during the study or within 6 months after the last dose of IMP.
  • Have a medical, psychological, or social condition which, in the opinion of the investigator, could compromise their wellbeing if they participate in the study, or that could prevent, limit, or confound the protocol-specified assessments or procedures, or that could impact adherence to protocol described requirements.
  • Have received any of the following therapies or drugs prior to the initiation of study:
  • Participants who received prior treatment with a PD(L)-1/Vascular Endothelial Growth Factor bispecific antibody.
  • Have received a systemic anticancer regimen within 4 weeks prior to the initiation of study treatment or have received palliative radiotherapy within 7 days prior to the initiation of study treatment, or have received any other chemotherapy, curative/palliative radiotherapy, biologic therapy (including tumor vaccines, cytokines, or growth factors for tumor control) or any experimental antitumor drugs within 4 weeks prior to the initiation of study treatment.
  • Have received other systemic immunostimulatory agents or immunosuppressive therapies (such as interferon-alpha [IFN-α], interleukin-2 [IL-2], or methotrexate) within 4 weeks prior to the initiation of study treatment or are within five half-lives of the treatment drug (whichever is longer). Exception: Excluding local, intranasal, intraocular, intra-articular or inhaled corticosteroids, short-term use (≤7 days) of corticosteroids for prophylaxis (e.g., prevention of contrast agent allergy) or treatment of non-autoimmune conditions (e.g., delayed hypersensitivity reactions caused by exposure to allergens).
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  • Have received systemic corticosteroids (at a dosage greater than 10 mg/day of prednisone or an equivalent dose of other corticosteroids) within 3 weeks prior to the initiation of study treatment.
  • Have been vaccinated with live attenuated vaccine(s) within 4 weeks prior to initiation of study treatment.
  • Received broad-spectrum IV antibiotics therapy within 3 weeks prior to initiation of study treatment.
  • Use of any non-study investigational medicinal product within five half-lives of first dose or within 4 weeks, whichever is longer, before initiation of study treatment in this study or ongoing participation in the active treatment phase of another interventional clinical study.
  • Have undergone major organ surgery (core needle biopsies are allowed >7 days prior study start), significant trauma, or invasive dental procedures (such as dental implants) within 28 days prior to the initiation of study treatment or plan to undergo elective surgery during the study. Placement of vascular infusion devices is allowed.
  • Have received allogeneic hematopoietic stem cell transplantation or organ transplantation.
  • Have spinal cord compression or central nervous system metastases that is untreated and symptomatic or requires treatment with corticosteroids or anticonvulsants for associated-symptom control. Exception: Treated brain metastases which is no longer symptomatic and for which no corticosteroid or anticonvulsant treatment is needed (the participant must be recovered from the acute toxic effect of radiotherapy; study treatment assignment must be ≥2 weeks after completion of radiotherapy).
  • Have active autoimmune disease that has required systemic treatment in the past 2 years (e.g., with use of disease modifying agents, corticosteroids, or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment. Those who had a history of autoimmune diseases with anticipated relapse (such as systemic lupus erythematosus, rheumatoid arthritis, vasculitis, etc.), except for those with clinically stable autoimmune thyroid disease or type 1 diabetes.
  • Have had other malignant tumors within 2 years prior to the study treatment are not allowed. Except for those: who have been cured with local treatment (such as basal cell or squamous cell carcinoma of the skin, superficial or non-invasive bladder cancer, carcinoma in situ of the cervix, ductal carcinoma in situ of the breast, and papillary carcinoma of thyroid; including prostate cancer with CR within the past 3 years).
  • Have any of the following heart conditions within 6 months prior to the study treatment:
  • Acute coronary syndrome, coronary artery bypass grafting, congestive heart failure, aortic dissection, stroke, or other Grade 3 and above cardiovascular and cerebrovascular events.
  • New York Heart Association functional classification ≥II heart failure or left ventricular ejection fraction <50%.
  • Those who have ventricular arrhythmias requiring clinical intervention, second- to third-degree atrioventricular block, or congenital long QT syndrome. Participants with treated cardiac arrythmia/atrial fibrillation are allowed.
  • Mean QT interval corrected by Fridericia's method (QTcF) >480 ms (the ECG can be repeated at the discretion of the investigator).
  • Use of cardiac pacemaker.
  • Cardiac troponin I or T >2 x ULN.
  • Have any of the following hypertension or diabetic conditions prior to initiation of study treatment:
  • Poorly controlled diabetes (fasting blood glucose ≥13.3 mmol/L [240 mg/dL] or HbA1C [≥8.5%]).
  • Uncontrolled hypertension (systolic blood pressure ≥150 mmHg and/or diastolic blood pressure ≥90 mmHg) while on antihypertensive medicine.
  • A history of hypertensive crisis or hypertensive encephalopathy.
  • Have serious non-healing wounds, ulcers, or bone fractures. This includes history of abdominal fistula, tracheoesophageal fistula, gastrointestinal perforation, or intra abdominal abscess for which an interval of 6 months must pass before the Screening Visit. In addition, the participant must have undergone correction (or spontaneous healing) of the perforation/fistula and/or the underlying process causing the fistula/perforation.
  • Participants with evidence of major coagulation disorders or other significant risks of hemorrhage such as:
  • History of intracranial hemorrhage or intraspinal hemorrhage.
  • Tumor lesions invading large blood vessels and are at significant risk of bleeding.
  • Had clinically significant hemoptysis or tumor hemorrhage of any cause within 1 month prior to the initiation of study treatment.
  • Have uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures (once monthly or more frequently). Participants with indwelling catheters (e.g., PleurX) are allowed.
  • Have uncontrolled tumor-related pain requiring analgesic treatment not managed by a stable analgesic regimen. For asymptomatic metastatic lesion, if its growth may cause dysfunction or intractable pain (e.g., current epidural metastasis unrelated to spinal cord compression), local treatment should be considered before screening, if appropriate.
  • Have a known or suspected hypersensitivity to the study treatments including any active ingredient or excipients thereof.
  • Have a known human immunodeficiency virus infection or known acquired immunodeficiency syndrome, with the following exceptions:
  • Participants with cluster of differentiation 4 (CD4)+ T-cell (CD4+) counts ≥350 cells/µL per local laboratory should generally be eligible for the study.
  • Participants who have not had an opportunistic infection within the past 12 months.
  • Have a known history/positive serology for hepatitis B requiring active antiviral therapy (unless immune due to vaccination or resolved natural infection or unless passive immunization due to immunoglobulin therapy). Individuals with positive serology must have hepatitis B virus viral load below the limit of quantification.
  • Have active hepatitis C virus infection; individuals who have completed curative antiviral treatment with hepatitis C virus viral load below the limit of quantification are allowed.
  • Are subject to exclusion periods from another investigational study.
  • Are vulnerable individuals, i.e., are individuals whose willingness to volunteer in a clinical study may be unduly influenced by the expectation, whether justified or not, of benefits associated with participation, or of a retaliatory response from senior members of a hierarchy in case of refusal to participate. This includes all sponsor, study site, or third party (e.g., CRO, vendor) personnel directly involved in the conduct of the study and their family members or dependents, as well as all study site personnel otherwise supervised by the investigator.
  • Participants with AEs from prior antitumor therapy that have not returned to Grade 1 (graded by NCI CTCAE version 5.0 criteria) or below (unless the investigator determines that certain AEs pose no safety risk to participants, such as hair loss, Grade 2 peripheral neuropathy or stable hypothyroidism under hormone replacement therapy) are not eligible for the study.
  • Have superior vena cava syndrome or symptoms of spinal cord compression.
  • Those with active, or a history of, pneumonitis requiring treatment with steroids, or has active, or a history of, interstitial lung disease. Those with a history of pulmonary fibrosis, or currently diagnosed with severe lung diseases such as interstitial pneumonia, pneumoconiosis, chemical pneumonitis, or any other condition resulting in significant impairment in lung function. Exception: Asymptomatic interstitial changes caused by previous radiation therapy, chemotherapy, or other factors such as smoking are acceptable.
  • Have active tuberculosis or history of tuberculosis that was not successfully treated.
  • Have underlying condition(s) that may increase risk of the combination treatment or complicate the interpretation of toxicities and AEs, as judged by the investigator, or other scenarios that the investigators consider the participant is not eligible for the study.

Trial locations and contacts

31 sites in 4 countries.

31 sites in 4 countries

United States13 sites

  • Beverly Hills Cancer Center

    Beverly Hills, California, 90211

  • Rocky Mountain Cancer Centers (RMCC)

    Denver, Colorado, 80220

  • The West Clinic, P.C. d/b/a West Cancer Center

    Germantown, Tennessee, 38138

  • Valkyrie Clinical Trials

    Los Angeles, California, 90067

  • Bon Secours St. Francis Medical Center

    Midlothian, Virginia, 23114

  • SCRI Oncology Partners

    Nashville, Tennessee, 37203

  • Rutgers Cancer Institute of NJ (Rutgers, The State University of New Jersey)

    New Brunswick, New Jersey, 08901

  • Yale University - Yale Cancer Center

    New Haven, Connecticut, 06520

  • Stanford University School of Medicine - Stanford Cancer Institute (SCI) - Stanford Women's Cancer Center

    Palo Alto, California, 94304-2201

  • HealthPartners Regions Specialty Clinics

    Saint Louis Park, Minnesota, 55426

  • Saint John's Health Center - John Wayne Cancer Institute (JWCI)

    Santa Monica, California, 90404-2312

  • Stony Brook University Hospital

    Stony Brook, New York, 11794

  • Carle Foundation Hospital d/b/a Carle Cancer Center

    Urbana, Illinois, 61801

Other trials in United States

Turkey (Türkiye)10 sites

  • Baskent Universitesi Tip Fakultesi Adana Hastanesi

    Adana, 01120

  • Medical Park Seyhan Hospital

    Adana, 01230

  • Sakarya University - Faculty of Medicine

    Adapazarı, 54290

  • Hacettepe Universitesi Kanser Enstitusu

    Ankara, 06100

  • Sbu Dr.A.Y. Ankara Onkoloji SUAM

    Ankara, 06100

  • Memorial Ankara Hospital

    Ankara, 06520

  • Koc Universitesi Hastanesi (Koc University Hospital)

    Istanbul, 34010

  • Bezmialem Vakif Universitesi Tip Fakultesi Hastanesi

    Istanbul, 34093

  • Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi

    Istanbul, 34722

  • Yeditepe University Hospital

    Istanbul, 34755

Other trials in Turkey (Türkiye)

United Kingdom6 sites

  • Hull and East Yorkshire Hospitals NHS Trust - Castle Hill Hospital

    Cottingham, HU16 5JQ

  • Edinburgh Cancer Centre-Western General Hospital

    Edinburgh, EH4 2XU

  • St James's University Hospital - Leeds Teaching Hospitals NHS Trust

    Leeds, LS9 7TF

  • St Bartholomew's Hospital - Barts Health NHS Trust

    London, EC1A 7BE

  • Sarah Cannon Research Institute

    London, W1G 6AD

  • University College London Hospitals NHS Foundation Trust

    London, W1T 7HA

Other trials in United Kingdom

Australia2 sites

  • Peninsula Oncology Centre

    Frankston, 3199

  • Peter MacCallum Cancer Centre

    Melbourne, 3050

Other trials in Australia

About this study

Official title: A Phase II, Multi-site, Randomized, Open-label Clinical Trial to Evaluate the Safety, Efficacy, and Pharmacokinetics of BNT327 at Two Dose Levels in Combination With Chemotherapeutic Agents as First- and Second-line Treatment in Triple-negative Breast Cancer

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).

Read the detailed description

Participants will be treated until disease progression, intolerable toxicity, participant withdrawal, death, study termination or up to 2 years (whichever occurs first).

The study plans to randomize or assign eligible participants into two cohorts, i.e., Cohort 1 and Cohort 2. In Cohort 1, participants will be randomized to two treatment arms investigating two dose levels of BNT327 in combination with Nab-paclitaxel. Participants in Cohort 2 will be assigned to one of three treatment arms by their clinician.

Cohort 2 will not begin until the appropriate dose to move forward has been determined from Cohort 1. After this, the arms in Cohort 2 exploring different chemotherapy combinations will begin to enroll.

Participants in Cohort 2, Arm 1 will receive the optimal dose of BNT327 in combination with paclitaxel. Participants in Cohort 2, Arms 2 and 3, will receive the equivalent dose of BNT327 administered once every 3 weeks (Q3W) in combination with gemcitabine plus carboplatin (Arm 2), or eribulin (Arm 3).

Being tested
BNT327 Dose Level 1 (DL1), BNT327 Dose Level 1 (DL2), Nab-placlitaxel, Carboplatin, Gemcitabine
Keywords
Programmed Death-1, Programmed Death Ligand-1, Programmed Death-1 monoclonal antibodies, Anti vascular endothelial growth factor-A (anti-VEGF-A)
Medical subject headings
Triple Negative Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BNT327 Dose Level 1 (DL1)Drug

    Intravenous (IV) infusion

  • BNT327 Dose Level 1 (DL2)Drug

    IV infusion

  • Nab-placlitaxelDrug

    IV infusion

  • CarboplatinDrug

    IV infusion

  • GemcitabineDrug

    IV infusion

  • PaclitaxelDrug

    IV infusion

  • EribulinDrug

    IV infusion

  • BNT327 Optimized DoseDrug

    IV infusion

  • BNT327 Equivalent Q3W DoseDrug

    IV infusion

Study groups in NCT06449222
Study groupRoleWhat they receive
Cohort 1 Arm 1 - BNT327 DL1 + Nab-paclitaxelExperimentalNot described
Receives: Drug: BNT327 Dose Level 1 (DL1); Drug: Nab-placlitaxel
Cohort 1 Arm 2 - BNT327 DL2 + Nab-paclitaxelExperimentalNot described
Receives: Drug: BNT327 Dose Level 1 (DL2); Drug: Nab-placlitaxel
Cohort 2 Arm 1 - BNT327 Optimized dose + PaclitaxelExperimentalNot described
Receives: Drug: Paclitaxel; Drug: BNT327 Optimized Dose
Cohort 2 Arm 2 - BNT327 Equivalent Q3W dose + Gemcitabine + CarboplatinExperimentalNot described
Receives: Drug: Carboplatin; Drug: Gemcitabine; Drug: BNT327 Equivalent Q3W Dose
Cohort 2 Arm 3 - BNT327 Equivalent Q3W dose + EribulinExperimentalNot described
Receives: Drug: Eribulin; Drug: BNT327 Equivalent Q3W Dose

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Occurrence of treatment emergent adverse events (TEAEs), adverse events of special interest (AESIs), treatment emergent serious adverse events (SAEs)

    In the combination treatment regimen according to the (US) National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events version 5.0 (CTCAE version 5.0). By treatment arm and overall.

    Measured: up to 100 days after the last dose of treatment

  2. Occurrence of dose interruption, dose reduction, and discontinuation of study treatment due to adverse events (AEs)

    By treatment arm and overall.

    Measured: up to 100 days after the last dose of treatment

  3. Objective Response Rate (ORR)

    Defined as the proportion of participants in whom a confirmed complete response (CR) or partial response (PR) (per Response Evaluation Criteria in Solid Tumors version 1.1 [RECIST 1.1] based on the investigator's assessment) is observed as best overall response. By treatment arm.

    Measured: Until end-of-treatment visit, i.e., up to 24 months after the first dose of treatment

  4. Best percentage change from baseline in the tumor size

    Based on the investigator's tumor assessment according to RECIST 1.1. Defined as the change from baseline in percent to the minimal tumor size until tumor progression/recurrence or death (whichever occurs first). By treatment arm.

    Measured: Until end-of-treatment visit, i.e., up to 24 months after the first dose of treatment

  5. Proportion of participants who have achieved early tumor shrinkage

    Defined as ≥10% decrease in the pretreatment sum of diameters at first post-treatment tumor scan in target lesions. By treatment arm.

    Measured: up to 4 months after first dose of treatment

Secondary outcomes (11)

  1. PK assessment: Maximum concentration (Cmax) derived from serum concentration of BNT327

    By treatment arm for Cohort 1, Arm 1 and 2, and Cohort 2, Arm 1

    Measured: from pre-dose to 15 days after study treatment

  2. PK assessment: Area Under the Curve During the Dosing Interval (AUCtau) derived from serum concentration of BNT327

    If data permits. By treatment arm for Cohort 1, Arm 1 and 2, and Cohort 2, Arm 1

    Measured: from pre-dose to 15 days after study treatment

  3. Incidence of detectable BNT327 antidrug antibodies in serum

    Measured: from pre-dose to 100 days after last dose of study treatment

  4. ORR as assessed by the investigator

    As assessed by the investigator (Cohort 2)

    Measured: Until end-of-treatment visit, i.e., up to 24 months after the first dose of treatment

  5. Duration of Response (DOR)

    Defined as the time from first objective response (CR or PR per RECIST 1.1) to first occurrence of objective tumor progression or death from any cause, whichever occurs first based on investigator's review

    Measured: Until end-of-treatment visit, i.e., up to 24 months after the first dose of treatment

  6. Disease Control Rate (DCR)

    Defined as the proportion of participants in whom a confirmed CR or PR or stable disease (per RECIST 1.1, stable disease assessed at least 6 weeks after first dose) is observed as best overall response based on the investigator's review.

    Measured: Until end-of-treatment visit, i.e., up to 24 months after the first dose of treatment

  7. Time to Response (TTR)

    Defined as the time from randomization/assignment to first objective response (CR or PR per RECIST 1.1) based on the investigator's review.

    Measured: Until end-of-treatment visit, i.e., up to 24 months after the first dose of treatment

  8. Progression-Free Survival (PFS)

    Based on investigator's review tumor assessment according to RECIST 1.1 is defined as the time from randomization/assignment to first confirmed objective tumor progression (progressive disease per RECIST 1.1), or death from any cause, whichever occurs first.

    Measured: up to 24 months after completion of study treatment of the last participant

  9. PFS rate

    As measured at 6, 12, 18, and 24 months

    Measured: up to 24 months after completion of study treatment of the last participant

  10. Overall Survival (OS)

    Defined as the time from randomization/assignment to death from any cause

    Measured: up to 24 months after completion of study treatment of the last participant

  11. OS rate

    As measured at 6, 12, 18, and 24 months

    Measured: up to 24 months after completion of study treatment of the last participant

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Jun 2024
  2. Study start26 Aug 2024
  3. Primary completionAug 2028 (estimated)
  4. Study completionJun 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
83 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06449222
Sponsor's protocol ID
BNT327-02
Status last verified
Jun 2026
First submitted
3 Jun 2024
Last updated
30 Jun 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Biteghe FAN, Mungra N, Malindi Z, Chalomie NET, Stanislas KA, Yasmin-Karim S, Mike Makrigiorgos G, Chipidza FE, Akinrinmade OA, Sridhar S, Barth S, Ngwa W. The Therapeutic Potential of Photoimmunotherapy as a Safe, Effective and Non-Toxic Treatment Option for Superficial Triple Negative Breast Cancer. Cancer Med. 2025 Sep;14(18):e71255. doi: 10.1002/cam4.71255.

    PubMed 40970572

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing BNT327 Dose Level 1 (DL1), BNT327 Dose Level 1 (DL2) and Nab-placlitaxel in people with Locally Advanced Breast Cancer and Triple Negative Breast Cancer, run by BioNTech SE at 31 sites in 4 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 32 inclusion and 46 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 30 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 31 sites in United States, Turkey (Türkiye), United Kingdom, Australia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Occurrence of treatment emergent adverse events (TEAEs), adverse events of special interest (AESIs), treatment emergent serious adverse events (SAEs) (time frame: up to 100 days after the last dose of treatment). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06449222, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jun 2026.

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