Pfizer Breast Cancer Clinical Trials
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Explore Pfizer’s Breast Cancer Clinical Trials as potential treatment options for your patients
- On Hold
- Recruiting
KATSIS-1
For adults with HR-positive, HER2-negative advanced or metastatic breast cancer whose disease progressed after prior line of treatment
The KATSIS-1 clinical trial is a phase 3, interventional, open-label, randomized multicenter study. It aims to learn about the safety and effects of the study medicine prifetrastat when given along with fulvestrant compared to an investigator’s choice of therapy for adult participants with HR-positive, HER2-negative advanced/metastatic breast cancer in participants whose disease has progressed after prior CDK4/6 inhibitor-based therapy.
Study details
- Phase 3, interventional, open-label, randomized, multicenter trial
- Evaluating:
- prifetrastat + fulvestrant
vs. - everolimus + exemestane or fulvestrant
- prifetrastat + fulvestrant
The primary endpoint is PFS as determined by BICR per RECIST v1.1. and key secondary endpoint is OS. Approximately 400 participants will be randomly assigned on a 1:1 basis:
Arm A:
- Prifetrastat tablet taken by mouth plus
- Fulvestrant taken as a shot into the muscle
Arm B: Investigator’s Choice of:
- Everolimus tablet taken by mouth plus
- Investigator’s choice of endocrine therapy of exemestane tablet taken by mouth or
- Fulvestrant taken as a shot into the muscle
Participant eligibility
- Key inclusion criteria:
- Confirmed diagnosis of HR-positive, HER2-negative breast cancer with evidence of locally advanced or metastatic disease, which is not amenable to surgical resection or radiation therapy with curative intent.
- Prior CDK4/6 inhibitor therapy in combination with endocrine therapy in advance metastatic setting or in adjuvant setting with documented progression during or within 12 months after the last dose of CDK4/6i.
- In addition, participants are eligible if they previously received CDK4/6i or ET as a monotherapy, or in combination for rechallenge therapy in the advance or metastatic setting; have received prior therapy targeting estrogen receptor 1 (ESR1) or breast cancer gene (BRCA)1/2.
- Measurable disease evaluable per Response Evaluation Criterion in Solid Tumors (RECIST) v.1.1 or non-measurable bone-only disease.
- Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0 or 1.
- Key exclusion criteria:
- Documented detectable PIK3CA/AKT1/PTEN alterations in tissue.
- Received greater than two prior lines of systemic therapy in the advance or metastatic setting.
- Had received any prior chemotherapy, including antibody drug conjugates (ADCs), in advance or metastatic setting. Participants who have previously received chemotherapy in the (neo)adjuvant setting are not excluded from the study.
- Any medical or psychiatric condition that may increase the risk of study participation or make the participant inappropriate for the study.
- Renal impairment, hepatic dysfunction, or hematologic abnormalities.
Please speak to the study team or a Pfizer Field Medical representative for the full eligibility criteria.
- On Hold
- Recruiting
DV-006
For patients with HER2-expressing advanced breast cancer
A study of the investigational medicine disitamab vedotin (DV) in patients with HER2-expressing locally advanced unresectable or metastatic breast cancer that has progressed on or after prior treatment.
Study details
The DV-006 clinical trial includes 3 parts: the screening period, treatment period, and follow-up period.
Study phases 1b/2
- Participants will be assigned to 1 of 3 cohorts in this clinical trial based on their type of breast cancer and the HER2 status of their tumor. All participants in this clinical trial will receive the study medicine, disitamab vedotin (DV). There is no placebo.
- Cohort 1: HR-negative/HER2-positive or HR-positive/HER2-positive
- Cohort 2: HR-positive/HER2-low
- Cohort 3: HR-negative/HER2-low (HER2-low TNBC) or HR-positive/HER2-ultralow
Participant eligibility
- Key inclusion criteria:
- Females and males aged 18 years or older
- Histologically or cytologically confirmed diagnosis of locally advanced unresectable or metastatic breast carcinoma
- HER2+: IHC 3+ or IHC 2+/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)
- Prior therapy requirements
- Cohorts 1 (HER2+, HR+ or HR- participants):
- No more than 3 prior lines of cytotoxic therapy in advanced disease setting
- Progression on, after, or intolerant to T-DXd in any line advanced disease setting
- Cohort 2 (HR+/HER2-low participants):
- No more than 3 prior lines of cytotoxic therapy in advanced disease setting
- Progression on, after, or intolerant to T-DXd in any line advanced disease setting
- Must have intolerance to endocrine therapy (ET) or ET refractory disease
- Cohort 3 (HR+/HER2-ultralow or HR-/HER2-low [HER2 low TNBC] participants):
- No more than 4 prior lines of cytotoxic therapy in advanced disease setting
- Prior T-DXd or sacituzumab govitecan is allowed
- Measurable disease per RECIST v1.1
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1
- Key exclusion criteria:
- Known hypersensitivity to any excipient contained in the drug formulation of disitamab vedotin (DV)
- Active central nervous system (CNS) and/or leptomeningeal metastasis
- History of other invasive malignancy within 3 years before 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 to first dose of study treatment
Explore Pfizer’s Breast Cancer Clinical Trials as potential treatment options for your patients
To learn more about Pfizer’s Breast Cancer Clinical Trials and how to refer potentially eligible patients, please complete the Contact Form and a member of the Pfizer Field Medical team will contact you.
You can also find the nearest study sites and their contact information by entering your postal code below.
Explore Pfizer’s Breast Cancer Clinical Trials as potential treatment options for your patients
The Pfizer Breast Cancer Clinical Trials are taking place at research sites in multiple countries worldwide.
To find your nearest study site, please enter your postal code and select the optimal distance to view on the map from the drop-down menu: