Clinical trial for Breast Cancer
Official title A Study to Learn About the Study Medicine Called PF-07248144 in Combination With Fulvestrant in People With HR-positive, HER2-negative Advanced or Metastatic Breast Cancer Who Progressed After a Prior Line of Treatment.
ClinicalTrials.gov ID: NCT07062965
What this study is testing
What is PF-07248144?
PF-07248144 is an investigational drug being studied for the possible treatment of hormone‑receptor positive, HER2‑negative advanced or metastatic breast cancer. PF-07248144 is designed to inhibit the KAT6 enzyme, which may affect cancer cell growth.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study looks at how safe and effective PF‑07248144 plus fulvestrant is for people whose breast cancer has progressed after CDK4/6 inhibitor treatment.
- Who it's for
- Adults with HR‑positive, HER2‑negative advanced or metastatic breast cancer that has worsened after CDK4/6 inhibitor therapy.
- What's involved
- Participants take a daily tablet of PF‑07248144 at home and receive fulvestrant injections at clinic visits. Half of the participants also take everolimus or exemestane tablets daily.
- Time commitment
- The study lasts several months, with regular clinic visits for injections and monitoring, and daily home medication for 28‑day cycles.
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Confirmed diagnosis of HR-positive HER2-negative breast cancer with evidence of locally advanced or metastatic disease, which is not amenable to...
- Prior CDK4/6 inhibitor therapy in combination with endocrine therapy in advance metastatic setting or in adjuvant setting with documented progression...
- Participants are eligible if they previously received CDK4/6i or ET as a monotherapy, or in combination for rechallenge therapy in the advance or...
- 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.
You likely can't join if
- 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.
- 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.
The study team makes the final eligibility decision.
Where it is enrolling
- Anchorage, Alaska, United States
- Chandler, Arizona, United States
- Gilbert, Arizona, United States
- Glendale, Arizona, United States
- Goodyear, Arizona, United States
- Mesa, Arizona, United States
- Phoenix, Arizona, United States
- Scottsdale, Arizona, United States
- Fayetteville, Arkansas, United States
- Rogers, Arkansas, United States
- Springdale, Arkansas, United States
- Anaheim, California, United States
- Camarillo, California, United States
- Fountain Valley, California, United States
- Glendale, California, United States
- Los Angeles, California, United States
- Oxnard, California, United States
- Palo Alto, California, United States
- Santa Barbara, California, United States
- Solvang, California, United States
+ 320 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Anchorage, Alaska, United States; Chandler, Arizona, United States; Gilbert, Arizona, United States; Glendale, Arizona, United States; Goodyear, Arizona, United States; Mesa, Arizona, United States and 334 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.