Bosutinib + Palbociclib + Fulvestrant for Advanced Breast Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores the combination of three drugs—bosutinib, palbociclib, and fulvestrant—to treat advanced breast cancer. The main goal is to determine a safe and effective dose level of these drugs together to see if they can slow or stop disease progression. Women with advanced breast cancer that is estrogen receptor-positive or progesterone receptor-positive, and HER2-negative, who have experienced progression despite previous treatments, might be suitable for this study. Participants will help researchers understand how best to use these medications in treating this type of cancer. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants a chance to be among the first to receive this combination therapy.
Do I need to stop my current medications to join the trial?
The trial does not specify if you need to stop all current medications, but you cannot use drugs that strongly affect CYP3A4, a liver enzyme. It's best to discuss your current medications with the trial team.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Previous studies have tested the combination of bosutinib, palbociclib, and fulvestrant for safety. Research shows that this combination undergoes careful study to ensure patient safety. Trials increase doses slowly to manage possible side effects.
Initial findings suggest the treatment is generally well-tolerated. However, side effects like fatigue or nausea can occur. The trial closely monitors these effects and adjusts doses as needed to enhance safety. While this combination remains under study, careful monitoring and dose adjustments aim to ensure participant safety.12345Why are researchers excited about this trial's treatments?
Researchers are excited about the combination of Bosutinib, Palbociclib, and Fulvestrant for advanced breast cancer because it targets cancer cells in a unique way. Unlike traditional treatments that might focus solely on hormone receptors or HER2 proteins, this combination uses a multi-faceted approach: Palbociclib inhibits cyclin-dependent kinases 4 and 6, potentially stopping cancer cell division; Bosutinib inhibits multiple tyrosine kinases, disrupting various pathways cancer cells use to grow; and Fulvestrant blocks and degrades estrogen receptors, cutting off a key growth signal. This triple-action strategy could offer a more comprehensive attack on cancer cells, potentially improving outcomes for patients with advanced stages of the disease.
What evidence suggests that this trial's treatments could be effective for advanced breast cancer?
This trial investigates a combination of three drugs—bosutinib, palbociclib, and fulvestrant—to treat advanced breast cancer that is hormone receptor-positive (HR+) and HER2-negative. Participants will receive varying doses of these drugs to assess their effectiveness in halting cancer cell growth. Previous studies have suggested that this combination might help when other treatments fail. Early results appear promising, but further research is necessary to confirm its efficacy. The trial aims to determine if this treatment can control advanced breast cancer when other options have not succeeded.12345
Who Is on the Research Team?
Claudine Isaacs, MD
Principal Investigator
Georgetown University
Are You a Good Fit for This Trial?
This trial is for adults over 18 with advanced breast cancer that's ER/PR positive and HER2 negative, who've had no more than three chemo treatments and are resistant to certain inhibitors. Participants must not be pregnant, should agree to contraception if of childbearing potential, have good organ function, and an ECOG status of 0-1 (fully active or restricted in physically strenuous activity but ambulatory).Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Dose Limiting Toxicity Observation
Observation period to determine dose-limiting toxicities and decide on dose escalation or de-escalation
Treatment
Participants receive Palbociclib, Bosutinib, and Fulvestrant until disease progression or unacceptable toxicity
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Bosutinib
- Fulvestrant
- Palbociclib
Bosutinib is already approved in United States for the following indications:
- Treatment of adult patients with chronic, accelerated or blast phase Philadelphia chromosome-positive (Ph+) chronic myelogenous leukemia (CML) with resistance, or intolerance to prior therapy
- Treatment of adult patients with newly-diagnosed chronic phase (CP) Philadelphia chromosome-positive chronic myelogenous leukemia (Ph+CML)
- Treatment of pediatric patients 1 year of age and older with chronic phase (CP) Philadelphia chromosome-positive chronic myelogenous leukemia (Ph+CML), newly-diagnosed or resistant or intolerant to prior therapy
Find a Clinic Near You
Who Is Running the Clinical Trial?
Georgetown University
Lead Sponsor
Pfizer
Industry Sponsor
Albert Bourla
Pfizer
Chief Executive Officer since 2019
PhD in Biotechnology of Reproduction, Aristotle University of Thessaloniki
Patrizia Cavazzoni
Pfizer
Chief Medical Officer
MD from McGill University