A study to learn more about the investigational drug PF-07220060 in combination with Letrozole in patients over 18 years of age with HR-positive, HER2-negative advanced/metastatic breast cancer who have not received prior systemic cancer therapy for advanced/metastatic disease (FourLight-3)
Zusammenfassung der Studie
The aim of this study is to determine the safety and efficacy of PF-07220060 in combination with Letrozole compared to approved treatments (i.e., Palbociclib, Ribociclib, or Abemaciclib in combination with Letrozole) in people with breast cancer: • with HR-positive tumor (breast cancer cells that require estrogen or progesterone to grow) • with HER2-negative tumor (cells that have little or no protein called HER2 on their surface) • with locally advanced cancer (the cancer has spread from its original site to nearby tissue or lymph nodes) or metastatic cancer (spread of cancer to other parts of the body) • who have not received prior systemic cancer treatment for advanced/metastatic disease. Approximately half of the participants will receive PF-07220060 in combination with Letrozole, while the other half will receive the treatment selected by the investigator in combination with Letrozole. The study team will monitor how participants respond to the study treatment during regular visit appointments at the study center.
(BASEC)
Untersuchte Intervention
Experimental therapy: Arm A
PF-07220060 tablet, taken by mouth, in combination with Letrozole tablet, taken by mouth
Active comparator: Arm B
Investigator-selected CDK4/6 inhibitor (tablet/capsule), taken by mouth together with Letrozole tablet
(BASEC)
Untersuchte Krankheit(en)
Breast cancer
(BASEC)
• Histological confirmation of breast cancer with evidence of locally advanced or metastatic disease that 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 • No prior treatment with systemic cancer therapy for locally advanced or metastatic disease • Measurable disease or non-measurable disease that only involves the bones, as defined by RECIST version 1.1 (BASEC)
Ausschlusskriterien
• There is a visceral crisis with the risk of immediate life-threatening complications in the short term • Current or previous metastases in the central nervous system • Previous (neo-)adjuvant endocrine therapy (ET) and recurrence during or within 12 months after the last dose of ET • Previous (neo-)adjuvant receipt of CDK4/6i and recurrence during or within 12 months after the last dose of CDK4/6i • Insufficient kidney function, liver dysfunction, or hematological abnormalities (BASEC)
Studienstandort
Aarau, Basel, Bern, Chur, Lausanne, Winterthur, Zürich, Andere
(BASEC)
Baden, Olten, Liestal, Frauenfeld
(BASEC)
Sponsor
Pfizer Inc. New York USA Pfizer AG Zürich Schweiz
(BASEC)
Kontakt für weitere Auskünfte zur Studie
Kontaktperson Schweiz
Martina Knecht Maier
+41 78 615 62 56
martina.knechtmaier@clutterpfizer.comPfizer AG
(BASEC)
Name der bewilligenden Ethikkommission (bei multizentrischen Studien nur die Leitkommission)
Ethikkommission Nordwest- und Zentralschweiz EKNZ
(BASEC)
Datum der Bewilligung durch die Ethikkommission
20.03.2025
(BASEC)
ICTRP Studien-ID
NCT06760637 (ICTRP)
Offizieller Titel (Genehmigt von der Ethikkommission)
An Interventional, Open-Label, Randomized, Multicenter Phase 3 Study of PF-07220060 Plus Letrozole Compared to CDK4/6 Inhibitor Plus Letrozole in Participants Over 18 Years of Age With Hormone Receptor (HR)-Positive, HER2-Negative Advanced/Metastatic Breast Cancer who Have not Received any Prior Systemic Anticancer Treatment for Advanced/Metastatic Disease (FOURLIGHT-3) (BASEC)
Wissenschaftlicher Titel
AN INTERVENTIONAL, OPEN-LABEL, RANDOMIZED, MULTICENTER PHASE 3 STUDY OF PF-07220060 PLUS LETROZOLE COMPARED TO CDK4/6 INHIBITOR PLUS LETROZOLE IN PARTICIPANTS OVER 18 YEARS OF AGE WITH HORMONE RECEPTOR (HR)-POSITIVE, HER2-NEGATIVE ADVANCED/METASTATIC BREAST CANCER WHO HAVE NOT RECEIVED ANY PRIOR SYSTEMIC ANTICANCER TREATMENT FOR ADVANCED/METASTATIC DISEASE (FOURLIGHT-3) (ICTRP)
Öffentlicher Titel
Study of PF-07220060 With Letrozole in Adults With HR-positive HER2-negative Breast Cancer Who Have Not Received Anticancer Treatment for Advanced/Metastatic Disease (ICTRP)
Untersuchte Krankheit(en)
Breast Cancer (ICTRP)
Untersuchte Intervention
Drug: PF-07220060Drug: letrozoleDrug: abemaciclibDrug: palbociclibDrug: ribociclib (ICTRP)
Studientyp
Interventional (ICTRP)
Studiendesign
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label). (ICTRP)
Ein-/Ausschlusskriterien
Inclusion 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
- Previously untreated with any systemic anticancer therapy for their locally advanced
or metastatic disease.
- Measurable disease or non-measurable bone only disease as defined by RECIST version
1.1
Exclusion Criteria:
- In visceral crisis at risk of immediately life-threatening complications in the
short term.
- Current or past history of central nervous system metastases.
- Have received prior (neo)adjuvant endocrine therapy (ET) and had recurrence during
or within 12 months after the last dose of ET.
- Have received prior (neo)adjuvant CDK4/6i and had recurrence during or within 12
months after the last dose of CDK4/6i.
- Inadequate renal function, hepatic dysfunction, or hematologic abnormalities. (ICTRP)
nicht verfügbar
Primäre und sekundäre Endpunkte
Progression Free Survival (PFS) by BICR (ICTRP)
Overall Survival (OS);Progression Free Survival (PFS) by Investigator;OR by BICR and by investigator;Duration of Response (DoR) by BICR and by investigator;Incidence of treatment emergent treatment related adverse events (AE);Incidence of treatment emergent treatment related serious adverse events;Estimated mean change from baseline in EORTC QLQ C30;Estimated mean change from baseline in BPI-SF;Estimated mean change from baseline in EQ-5D-5L;Estimated mean change from baseline in EORTC Breast Cancer Module (BR42);Mean change from baseline of ctDNA (ICTRP)
Registrierungsdatum
11.12.2024 (ICTRP)
Einschluss des ersten Teilnehmers
nicht verfügbar
Sekundäre Sponsoren
nicht verfügbar
Weitere Kontakte
Pfizer CT.gov Call CenterPfizer CT.gov Call Center, ClinicalTrials.gov_Inquiries@pfizer.com, 1-800-718-1021, Pfizer (ICTRP)
Sekundäre IDs
2024-512925-95-00, C4391024 (ICTRP)
Angaben zur Verfügbarkeit von individuellen Teilnehmerdaten
nicht verfügbar
Weitere Informationen zur Studie
https://clinicaltrials.gov/study/NCT06760637 (ICTRP)
Ergebnisse der Studie
Zusammenfassung der Ergebnisse
nicht verfügbar
Link zu den Ergebnissen im Primärregister
nicht verfügbar