C4551002 - Phase 3, HR-positive, HER2-negative Advanced or Metastatic Breast Cancer

• Research type

  Research Study

• Full title

  An Interventional, Open-Label, Randomized, Multicenter, Phase 3 Study of PF-07248144 Plus Fulvestrant Compared to Investigator’s Choice of Therapy in Adult Participants with Hormone Receptor-Positive, HER2-Negative Advanced/Metastatic Breast Cancer Whose Disease Progressed After Prior CDK4/6 Inhibitor-based Therapy

• IRAS ID

  1012362

• Contact name

  Tatjana Djerkovic

• Sponsor organisation

  Pfizer Inc.

• Research summary

  The purpose of the study is to evaluate whether PF-07248144 in combination with fulvestrant can improve clinical outcomes in participants with HR-positive, HER2-negative A/Mbc who have progressed after prior CDK 4/6 inhibitor-based therapy.
  The study doctor will determine eligibility of participants who will need to visit the study site and the frequency of which they will receive the study drug and for study assessments.
  Study procedures will include collecting information about participants’ health status and side effects, performing blood and urine tests, body scans such as CT and/or MRI to assess tumours, and collecting existing or new biopsies if applicable.
  Participants may need to visit the study site more frequently if needed. Procedures will be conducted on bones, chest, abdomen, pelvis and brain, and some will be conducted on the whole body.
  All known risks are considered manageable and will be monitored and managed according to the protocol and institutional standard of care. PF-07248144 in combination with fulvestrant has demonstrated favourable preliminary benefit/risk profile to support the rationale for this trial. The study doctor will explain potential risks and discomforts.
  The median time of disease progression is 6 months. The median survival time is 24 months, the maximum time participants will remain on the study is 5 years.

• REC name

  London - South East Research Ethics Committee

• REC reference

  25/LO/0855

• Date of REC Opinion

  15 Jan 2026

• REC opinion

  Further Information Favourable Opinion