PF-07104091 for Breast Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new cancer treatment called PF-07104091 to evaluate its safety and effectiveness for difficult-to-treat cancers, such as certain advanced breast, lung, and ovarian cancers. The trial includes different groups trying PF-07104091 alone or in combination with other cancer drugs. Eligible participants have specific cancer types that have recurred or spread after previous treatments. Participants must have tried other treatments without success. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.
Will I have to stop taking my current medications?
The trial does not specify if you must stop taking your current medications, but it does mention that you cannot use certain drugs that affect liver enzymes (CYP3A4/5 or UGT1A9 inhibitors or inducers) or drugs that are sensitive UGT1A1 substrates. 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?
Research has shown that PF-07104091, a CDK2 inhibitor, has been tested for safety in people with advanced cancers. Early studies found it to be generally well-tolerated when used alone, with most participants not experiencing severe side effects. Similar drugs, like BLU-222, also appear safe for people with advanced cancer.
When combined with other drugs like palbociclib and letrozole or fulvestrant, studies have found these combinations to be safe and tolerable. Specifically, the combination of palbociclib and letrozole has helped breast cancer patients without causing unexpected side effects. Similarly, using palbociclib with fulvestrant has been generally safe, according to past research. Long-term studies have not identified any new safety concerns.
In summary, PF-07104091, whether used alone or with other cancer treatments, has demonstrated a promising safety profile in previous studies. This suggests it is generally well-tolerated, with no major unexpected side effects reported so far.12345Why are researchers excited about this trial's treatments?
Researchers are excited about PF-07104091 for breast cancer because it targets CDK2, a protein that plays a crucial role in cell division, offering a new approach compared to current treatments that typically target CDK4/6. Unlike standard therapies like palbociclib or letrozole, PF-07104091 can be combined with these drugs for a potentially more effective treatment. Its unique mechanism of action could potentially overcome resistance to existing therapies, making it a promising option for patients who have limited responses to current treatments.
What evidence suggests that this trial's treatments could be effective for breast cancer?
Research shows that PF-07104091 is a promising new treatment for cancers, including breast cancer. In this trial, some participants will receive PF-07104091 alone. Studies have shown that this treatment stopped cancer growth in some patients, while others experienced slight tumor shrinkage. Other participants will receive PF-07104091 combined with drugs like palbociclib and letrozole. Studies have shown that patients with advanced breast cancer lived almost 25 months without their cancer worsening with this combination. Additionally, the combination with fulvestrant has also shown potential benefits for breast cancer patients. These findings suggest that PF-07104091 may effectively treat breast cancer, especially when used with other therapies.26789
Who Is on the Research Team?
Pfizer CT.gov Call Center
Principal Investigator
Pfizer
Are You a Good Fit for This Trial?
This trial is for adults with certain advanced cancers: small cell lung cancer (SCLC), ovarian, or breast cancer. Participants must have a performance status of 0 or 1, indicating they are fully active or restricted in physically strenuous activity but can do light work. They should have received prior treatments specific to their cancer type and must not have any serious heart conditions, uncontrolled infections, recent major surgeries, other active malignancies within the last three years, or be pregnant.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Dose Escalation
Participants receive increasing doses of PF-07104091 to assess safety and determine the Maximum Tolerated Dose (MTD)
Dose Expansion
Participants receive the Recommended Phase 2 Dose (RP2D) to further evaluate safety and antitumor activity
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- PF-07104091
Find a Clinic Near You
Who Is Running the Clinical Trial?
Pfizer
Lead 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