A Study to Learn About the Study Medicine Called PF-07220060 in Combination With Fulvestrant in People With HR-positive, HER2-negative Advanced or Metastatic Breast Cancer Who Progressed After a Prior Line of Treatment

JRCT ID: jRCT2051230196

Registered date:11/03/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: HR-positive, HER2-negative Advanced or Metastatic Breast Cancer
• Date of first enrollment: 09/04/2024
• Target sample size: 510
• Countries of recruitment: United States,Japan,Argentina,Japan,Australia,Japan,Brazil,Japan,Canada,Japan,Israel,Japan,Korea, Republic of,Japan,Taiwan,Japan
• Study type: Interventional

Intervention(s)

Arm A (Experimental Arm)
PF-07220060 plus Fulvestrant

Arm B (Active Comparator)
Fulvestrant monotherapy
or
Everolimus plus Exemestane

Outcome(s)

• Primary Outcome: Progression-Free Survival (PFS) by blinded independent central review (BICR) per RECIST v1.1

Secondary Outcome

1. Overall Survival (OS)
2. PFS by investigator
3. Objective Response (OR) by BICR and investigator
4. Duration of Response (DOR) by BICR and by investigator
5. Clinical Benefit Response (CBR) by BICR and by investigator
6. Adverse Events (AEs) including type, incidence, seriousness, relationship to study interventions
7. Abnormal Electrocardiogram (ECG)
8. Laboratory Test Abnormalities
9. Patient reported outcome (PRO) including EQ-5D-5L, EORTC QLQ and EORTC QLQ BR23
10. Ctrough of PF-07220060

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

* Histological confirmation of breast cancer with evidence of locally advanced or metastatic disease, which is not amenable to surgical resection or radiation therapy with curative intent.
* Documented estrogen receptor (ER) and/or progesterone receptor (PR)- positive tumor
* Documented HER2-negative tumor
* Able to provide a sufficient amount of representative formalin fixed, paraffin embedded (FFPE) tumor tissue specimen.
* Must have received CDK4/6i + NSAI defined per study protocol. There must be documented PD during or after CDK4/6i treatment.
* Measurable disease or non-measurable bone only disease as defined by RECIST version 1.1.
* Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 2 or less

Exclude criteria

* Any medical or psychiatric condition that may increase the risk of study participation or make the participant inappropriate for the study.
* In visceral crisis at risk of immediately life-threatening complications in the short term.
* Known active uncontrolled or symptomatic central nervous system metastases, carcinomatous meningitis, or leptomeningeal disease.
* Prior treatment with any of the following:
* Everolimus or investigational anti-cancer agents in any setting; Prior chemotherapy in the advanced setting; Radiation within 2 weeks of randomization
* Current use or anticipated need for any prohibited food, supplements or concomitant medication(s) (ie, other anti-cancer therapies, growth factors, chronic systemic corticosteroids, strong and moderate cytochrome P450 3A4/5 [CYP3A4/5] or uridine 5' diphosphate-glucuronosyltransferase 2B7 [UGT2B7] inhibitors and inducers, direct oral anticoagulants, proton pump inhibitors).
* Inadequate renal function, hepatic dysfunction, or hematologic abnormalities.

Related Information

• Primary Sponsor: Kawai Norisuke
• Secondary ID(s): NCT06105632