A PHASE 1b/2, OPEN-LABEL, MULTICOHORT STUDY OF DISITAMAB VEDOTIN IN ADULTS WITH HER2 EXPRESSING ADVANCED BREAST CANCER

New drug trial for advanced breast cancer with HER2 expression

NCT: NCT06966453 · Status: RECRUITING · Phase: Phase 2 · Sponsor: Pfizer · Started: 2025-06-30 · Est. Completion: 2030-01-27

Plain English Summary

A Study of Disitamab Vedotin in Adults With HER2 Expressing Advanced Breast Cancer is a Phase 2 clinical trial sponsored by Pfizer studying Breast Cancer, Breast Neoplasms. This trial tests a new drug called disitamab vedotin for adults with advanced breast cancer that has spread and has HER2 on its tumors. It is for patients who have already received prior treatments for their advanced breast cancer. Participants will receive the study drug intravenously (into a vein) every two weeks. There are no alternative treatments offered within this specific trial; patients may discuss other options with their doctor. The trial aims to enroll 100 participants.

Official Summary

The purpose of this clinical study is to learn about the safety and effects of the study medicine (called disitamab vedotin) for the possible treatment of people with breast cancer that is hard to treat and has spread in the body (advanced cancer). This study is seeking participants who: * have breast cancer that is hard to treat and has spread in the body (advanced cancer) * have tumors that have HER2 on them * have received previous treatment for their advanced breast cancer All participants in this study will receive disitamab vedotin at the study clinic once every 2 weeks as an intravenous (IV) infusion (given directly into a vein). Participants will take the study medicine until they or their doctor decides to stop. This might be because their cancer is getting worse, the study medicine is no longer helping, they have bad side effects, or they wish to stop taking the study medicine. During this time, the participants will have study visits every 2 weeks. After the participants have stopped taking the study medicine, they will have follow-up visits about every 6 weeks unless their cancer gets worse. After that, they will have follow-up phone calls about every 12 weeks. The study team will look at the experiences of people receiving the study medicine. This will help the study team decide if the study medicine is safe and effective.

Who Can Participate

Here is what you need to know about eligibility for this trial. Adults with breast cancer that has spread and cannot be removed by surgery. Patients whose tumors have a specific protein called HER2 (either HER2-low or HER2-high). Individuals who have previously been treated for their advanced breast cancer and their cancer has progressed or they could not tolerate the treatment. Patients must not have active cancer spread to the brain or spinal cord, and must not have had certain other cancer treatments recently. This trial is studying Breast Cancer, Breast Neoplasms, so participants generally need a confirmed diagnosis. The trial is currently accepting new participants.

What They're Measuring

The primary outcome measures how well the study drug shrinks tumors, which is important for patients as it indicates the treatment may be controlling their cancer. The specific primary outcome measures are: Objective response (OR) by investigator assessment (From Cycle 1 Day 1 until disease progression by investigator assessment per RECIST version 1.1, or death due to any cause, whichever is earlier; up to approximately 2 years). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.

About This Phase

This trial is in Phase 2, which tests whether the treatment actually works against the target condition. Phase 2 trials involve 100-300 patients and continue to monitor safety while evaluating effectiveness. This phase often tests different dosages to find the optimal amount. About 33% of Phase 2 drugs advance to Phase 3. If successful, the treatment will move to large-scale Phase 3 trials needed for FDA approval.

Why This Trial Matters

This trial addresses a need for new treatments for advanced breast cancer, particularly for patients whose cancer expresses HER2 and has not responded to previous therapies. Phase 2 success would typically lead to larger Phase 3 trials needed for regulatory approval. This research targets Breast Cancer, Breast Neoplasms, where improved treatment options are needed.

Investor Insight

This trial is investigating a targeted therapy for a significant patient population in breast cancer, suggesting potential for a new treatment option if successful, which could impact the market for H Phase 2 trials have approximately a 15-20% chance of eventually gaining FDA approval.

Is This Trial Right for Me?

Ask your doctor if your breast cancer is HER2-positive or HER2-low, and if you have received prior treatments that make you eligible. Participation involves regular visits to the study clinic for drug infusions and monitoring, which will continue as long as the treatment is beneficial or tolerated. Be prepared for regular follow-up visits and phone calls even after treatment stops to monitor your health and cancer status. This trial is currently recruiting participants. The trial is being conducted at 20 sites. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.

AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.

Study Design

Interventions

Primary Outcomes

Secondary Outcomes

Full Eligibility Criteria

Inclusion Criteria:

* Histologically or cytologically confirmed diagnosis of locally-advanced, unresectable, or metastatic breast carcinoma.
* Human epidermal growth factor receptor 2 (HER2) and hormone receptor (HR) status appropriate for enrollment in cohort.
* HER2 status determined by most recent local assessment based on American Society of Clinical Oncology (ASCO) and College of American Pathologists (CAP) guidelines for assessment of HER2 in BC for interpretation of HER2 expression and amplification
* HER2+: immunohistochemistry (IHC) 3+ or IHC 2+/in situ hybridization (ISH)+
* HER2-low: IHC 1+/ISH-negative or untested or IHC 2+/ISH-negative
* HER2-ultralow: IHC 0 with membrane staining (any staining of the membrane in \>0 and ≤10% of cancer cells) o HR+ disease is determined as either estrogen receptor (ER) and/or progesterone receptor (PgR) positive \[ER or PgR ≥1%\]) and HR negative disease is determined as both ER and PR negative \[ER and PgR \<1%\]) per ASCO/CAP guidelines in the advanced disease setting. If a patient has had multiple ER/PgR results for advanced disease, the most recent test result will be used to confirm eligibility.

Prior therapy requirements for Cohort 1 (HER2+, HR+ or HR- participants):

* Received prior trastuzumab, pertuzumab and a taxane if available as local first line standard of care therapy for advanced disease.
* Prior tucatinib based therapy is allowed.
* Must have progression on or after, or be intolerant to, T-DXd in any line advanced disease setting.
* No more than 3 prior systemic cytotoxic therapy regimens (including antibody drug conjugates \[ADCs\]) for Locally Advanced (LA)/metastatic breast cancer (mBC). Participants previously treated with (neo)adjuvant cytotoxic therapy and have disease relapsed within 6 months of cytotoxic treatment is considered to have received 1 line of cytotoxic therapy for LA/mBC.

Prior therapy requirements for Cohort 2 (HR+/HER2-low participants):

* No more than 3 prior systemic cytotoxic therapy regimens (including ADCs) for LA/mBC. Participants previously treated with (neo)adjuvant cytotoxic therapy and have disease relapsed within 6 months of cytotoxic treatment is considered to have received 1 line of cytotoxic therapy for LA/mBC.
* Participants with known germline breast cancer gene (BRCA) mutation must have received a poly-ADP ribose polymerase (PARP) inhibitor, where available and not medically contraindicated.
* Must have progression on or after, or be intolerant to, trastuzumab deruxtecan (T-DXd) in any line advanced disease setting.
* Must have intolerance to endocrine therapy (ET) or ET refractory disease:
* Progressed on ≥2 lines of ET for LA/mBC AND had received a cyclin-dependent kinase (CDK)4/6 inhibitor in the adjuvant or metastatic setting if available as local standard of care and not contraindicated.

OR

• Progressed on 1 line of ET for LA/mBC AND had a relapse while on adjuvant ET after definitive surgery for primary tumor AND had received a cyclin-dependent kinase (CDK) 4/6 inhibitor in the adjuvant or advanced setting if available as local standard of care and not contraindicated.

Prior therapy requirements for Cohort 3 (HR+/HER2-ultralow or HR-/HER2-low \[HER2 low TNBC\] participants):

* No more than 4 prior systemic cytotoxic chemotherapy regimens (including ADCs) for advanced or mBC. Participants previously treated with (neo)adjuvant cytotoxic therapy and have disease relapsed within 6 months of cytotoxic treatment is considered to have received 1 line of cytotoxic therapy for LA/mBC.
* Known germline BRCA mutation must have received a PARP-inhibitor if available as local standard of care therapy and not medically contraindicated.
* Prior sacituzumab govitecan is allowed.
* Prior T-DXd is allowed.
* Participants with HR negative (TNBC), HER2-low and programmed cell death receptor ligand 1 (PD-L1)-positive (combined positive score \[CPS\] ≥10) tumors must have received pembrolizumab (or other PD-L1 inhibitor) with chemotherapy if available as local standard of care therapy and not medically contraindicated.
* Participants with HR+/HER2-ultra low tumors must have received at least 1 antihormonal therapy in any setting or be ineligible for ET.
* Participants with HR+/HER2-ultra low tumors must have had prior therapy with a CDK4/6 inhibitor in the adjuvant or advanced setting.

Exclusion Criteria:

* Known hypersensitivity to any excipient contained in the drug formulation of disitamab vedotin.
* Active central nervous system (CNS) and/or leptomeningeal metastasis.
* Participants with a history of other invasive malignancy within 3 years before the Cycle 1 Day 1 (C1D1) of study intervention, or any evidence of residual disease from a previously diagnosed malignancy.
* Prior therapy with ADCs with MMAE payload.
* Participants who have received prior systemic anticancer treatment or radiotherapy within 2 weeks, or 5 half-lives, whichever is shorter, prior to C1D1 of study intervention. Note: If the last im

Trial Locations

Frequently Asked Questions

What is clinical trial NCT06966453?

NCT06966453 is a Phase 2 INTERVENTIONAL study titled "A Study of Disitamab Vedotin in Adults With HER2 Expressing Advanced Breast Cancer." It is currently recruiting and is sponsored by Pfizer. The trial targets enrollment of 100 participants.

What conditions does NCT06966453 study?

This trial investigates treatments for Breast Cancer, Breast Neoplasms. The primary condition under study is Breast Cancer.

What treatments are being tested in NCT06966453?

The interventions being studied include: Disitamab vedotin (DRUG). Given into the vein (IV; intravenous) every 2 weeks.

What does Phase 2 mean for NCT06966453?

Phase 2 trials test whether the treatment works for the intended condition. They involve 100-300 patients and continue to evaluate safety while measuring effectiveness.

What is the current status of NCT06966453?

This trial is currently "Recruiting." It started on 2025-06-30. The estimated completion date is 2030-01-27.

Who is sponsoring NCT06966453?

NCT06966453 is sponsored by Pfizer. The sponsor is responsible for funding, designing, and overseeing the clinical trial.

How many people can participate in NCT06966453?

The trial aims to enroll 100 participants. The trial is currently recruiting and accepting new participants.

How is NCT06966453 designed?

This is a interventional study, uses non_randomized allocation, follows a parallel design, employs none masking.

What are the primary outcomes being measured in NCT06966453?

The primary outcome measures are: Objective response (OR) by investigator assessment (From Cycle 1 Day 1 until disease progression by investigator assessment per RECIST version 1.1, or death due to any cause, whichever is earlier; up to approximately 2 years). These are the main endpoints researchers use to determine whether the treatment is effective.

Where is NCT06966453 being conducted?

This trial is being conducted at 20 sites, including Daphne, Alabama; Foley, Alabama; Mobile, Alabama; Gilbert, Arizona and 16 more sites (United States).

Where can I find official information about NCT06966453?

The official record for NCT06966453 is available on ClinicalTrials.gov at https://clinicaltrials.gov/study/NCT06966453. This government database provides the most up-to-date and detailed information about the trial.

What is NCT06966453 testing in simple terms?

This trial tests a new drug called disitamab vedotin for adults with advanced breast cancer that has spread and has HER2 on its tumors. It is for patients who have already received prior treatments for their advanced breast cancer.

Why is this trial significant?

This trial addresses a need for new treatments for advanced breast cancer, particularly for patients whose cancer expresses HER2 and has not responded to previous therapies.

What are the potential risks of participating in NCT06966453?

Common side effects may include fatigue, nausea, low white blood cell counts, and mouth sores. There is a risk of serious side effects, including lung problems, liver problems, and severe allergic reactions. The drug may affect fertility, and it is important to discuss this with your doctor if you plan to have children. As with any clinical trial, participants are closely monitored and can withdraw at any time.

Should I consider participating in NCT06966453?

Ask your doctor if your breast cancer is HER2-positive or HER2-low, and if you have received prior treatments that make you eligible. Participation involves regular visits to the study clinic for drug infusions and monitoring, which will continue as long as the treatment is beneficial or tolerated. Be prepared for regular follow-up visits and phone calls even after treatment stops to monitor your health and cancer status. Always discuss clinical trial participation with your healthcare provider to determine if it is appropriate for your specific situation.

What does NCT06966453 signal from an investment perspective?

This trial is investigating a targeted therapy for a significant patient population in breast cancer, suggesting potential for a new treatment option if successful, which could impact the market for H This is a Phase 2 trial, which is focused on confirming efficacy before larger pivotal studies.

What happens if the treatment in this trial doesn't work?

Participants will receive the study drug intravenously (into a vein) every two weeks. Participants in clinical trials always have the right to withdraw and pursue alternative treatments. The study team will help transition patients to other available options.

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This analysis is AI-generated and does not constitute medical advice. Always consult your healthcare provider before making decisions about clinical trial participation.