Palbociclib in Combination With Fulvestrant or Letrozole in Patients With ER+, HER2- Advanced Breast Cancer

NCT02491983 | Completed Phase 2 Results

• 2 other identifiers: MedOPP0672014-004698-17
• Study Type: interventional
• Target: 486
• Locations: 7 countries
• Sites: 48

Brief Summary

This is an international, randomized, open-label, controlled, multicenter phase II clinical trial to investigate and compare the safety and efficacy of palbociclib combined with fulvestrant or letrozole in women with ER+, HER2- locally advanced or metastatic breast cancer.

Conditions

Metastatic Breast Cancer

Keywords

metastatic breast cancer; Endocrine receptors positive; HER-2 negative

Outcome Measures

Primary Outcomes (1)

• 1-year Progression Free Survival

  Percentage of patients who are alive and without evidence of tumor progression (defined using RECIST v1.1)

  One year

Secondary Outcomes (5)

• Number of Participants With Grade 3/4 Adverse Events, SAEs, Deaths and Discontinuations •

  Through study completion. From baseline up to 51 months.

• Time To Progression (TTP)

  Through study completion. From baseline up to 51 months.

• Overall Survival (OS)

  Through study completion. From baseline up to 51 months.

• Clinical Benefit Rate

  Through study completion. From baseline up to 51 months.

• Overall Response Rate

  Through study completion. From baseline up to 51 months.

Study Arms (2)

Arm A

ACTIVE COMPARATOR

Combination of Palbociclib and Letrozole

Drug: Palbociclib; Drug: Letrozole

Arm B

EXPERIMENTAL

Combination of Palbociclib and Fulvestrant

Drug: Palbociclib; Drug: Fulvestrant

Interventions

Palbociclib DRUG

Also known as: PD-0332991

Arm A; Arm B

Fulvestrant DRUG

Also known as: Faslodex

Arm B

Letrozole DRUG

Also known as: Femara

Arm A

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Women 18 years or older with metastatic or locally advanced disease, not amenable to curative therapy
• Confirmed diagnosis of HR+/HER2- breast cancer
• Post-menopausal status
• No prior chemotherapy line in the metastatic setting
• Measurable disease defined by RECIST version 1.1, or non-measurable disease
• Eastern Cooperative Oncology Group (ECOG) PS 0-1
• Adequate organ and marrow function, resolution of all toxic effects of prior therapy or surgical procedures
• Resolution of all acute toxic effects of prior anti-cancer therapy or surgical procedures to NCICTCAE version 4.0 Grade equal or minor than 1

You may not qualify if:

• ER or HER2 unknown disease
• HER2 positive disease based on local laboratory results
• Locally advanced breast cancer candidate for a radical treatment
• Prior (neo)adjuvant endocrine treatment with DFI ≤ 12-months from completion of treatment.
• Patients with rapidly progressive visceral disease or visceral crisis.
• Major surgery within 4 weeks of start of study drug
• Patients with an active, bleeding diathesis
• Serious concomitant systemic disorder incompatible with the study
• Are unable to swallow tablets
• Chronic daily treatment with corticosteroids with a dose of ≥ 10mg/day methylprednisolone equivalent
• Known active uncontrolled or symptomatic CNS metastases
• Known hypersensitivity to letrozole, fulvestrant or any of their excipients, or to any PD-0332991 excipients
• QTc \> 480 msec on basal assessments, personal history of long or short QT syndrome, Brugada syndrome or known history of QTc prolongation, or Torsade de Pointes
• Uncontrolled electrolyte disorders that can compound the effects of a QTc-prolonging drug

Sponsors & Collaborators

• MedSIR: lead

Study Sites (48)

MedSIR investigative site

Olomouc, 77600, Czechia

Location

MedSIR investigative site

Prague, 12000, Czechia

Location

MedSIR investigative site

Prague, 15006, Czechia

Location

MedSIR investigative site

Paris, 75005, France

Location

MedSIR investigative site

Paris, 75015, France

Location

MedSIR investigative site

Paris, 75020, France

Location

MedSIR investigative site

Strasbourg, 67065, France

Location

MedSIR investigative site

Toulouse, 31059, France

Location

MedSIR investigative site

Dessau, 06847, Germany

Location

MedSIR investigative site

Heidelberg, 69120, Germany

Location

MedSIR investigative site

Brindisi, 72021, Italy

Location

MedSIR investigative site

Cagliari, 09134, Italy

Location

MedSIR investigative site

Cremona, 26100, Italy

Location

MedSIR investigative site

Milan, 20133, Italy

Location

MedSIR investigative site

Milan, 20141, Italy

Location

MedSIR investigative site

Modena, 41124, Italy

Location

MedSIR investigative site

Monza, 20052, Italy

Location

MedSIR investigative site

Piacenza, Italy

Location

MedSIR investigative site

Torino, 10126, Italy

Location

MedSIR investigative site

Moscow, 115478, Russia

Location

MedSIR investigative site

Moscow, 125284, Russia

Location

MedSIR investigative site

Saint Petersburg, 197758, Russia

Location

MedSIR investigative site

Yaroslavl, 150040, Russia

Location

MedSIR investigative site

Barcelona, 08003, Spain

Location

MedSIR investigative site

Barcelona, 08035, Spain

Location

MedSIR investigative site

Barcelona, 08908, Spain

Location

MedSIR investigative site

Bilbao, 48013, Spain

Location

MedSIR investigative site

Castelló, 12002, Spain

Location

MedSIR investigative site

Cáceres, 10003, Spain

Location

MedSIR investigative site

Córdoba, 14004, Spain

Location

MedSIR investigative site

Girona, 17007, Spain

Location

MedSIR investigative site

Huelva, 21005, Spain

Location

MedSIR investigative site

Madrid, 28046, Spain

Location

MedSIR investigative site

Oviedo, 33011, Spain

Location

MedSIR investigative site

Pamplona, 31008, Spain

Location

MedSIR investigative site

Santiago de Compostela, 15706, Spain

Location

MedSIR investigative site

Seville, 41013, Spain

Location

MedSIR investigative site

Tarragona, 43005, Spain

Location

MedSIR investigative site

Valencia, 46009, Spain

Location

MedSIR investigative site B

Zaragoza, 50009, Spain

Location

MedSIR investigative site

Zaragoza, 50009, Spain

Location

MedSIR investigative site

Bath, BA1 3NG, United Kingdom

Location

MedSIR investigative site

London, EC1M 6BQ, United Kingdom

Location

MedSIR investigative site

Manchester, M20 4 BX, United Kingdom

Location

MedSIR investigative site

Nottingham, NG5 1PB, United Kingdom

Location

MedSIR investigative site

Romford, RM7 0AG, United Kingdom

Location

MedSIR investigative site

Swansea, SA2 8QA, United Kingdom

Location

MedSIR investigative site

Truro, TR1 3LQ, United Kingdom

Location

Related Publications (2)

• Di Cosimo S, Perez-Garcia JM, Bellet M, Dalenc F, Gil Gil MJ, Ruiz Borrego M, Gavila J, Sampayo-Cordero M, Aguirre E, Schmid P, Marme F, Gligorov J, Schneeweiss A, Albanell J, Zamora P, Wheatley D, Martinez-De Duenas E, Caranana V, Amillano K, Mina L, Malfettone A, Cortes J, Llombart-Cussac A. Palbociclib with Fulvestrant or Letrozole in Endocrine-Sensitive Patients with HR-Positive/HER2-Negative Advanced Breast Cancer: A Detailed Safety Analysis of the Randomized PARSIFAL Trial. Oncologist. 2023 Jan 18;28(1):23-32. doi: 10.1093/oncolo/oyac205.

  PMID: 36239405 DERIVED

• Llombart-Cussac A, Perez-Garcia JM, Bellet M, Dalenc F, Gil-Gil M, Ruiz-Borrego M, Gavila J, Sampayo-Cordero M, Aguirre E, Schmid P, Marme F, Di Cosimo S, Gligorov J, Schneeweiss A, Albanell J, Zamora P, Wheatley D, Martinez-de Duenas E, Amillano K, Malfettone A, Cortes J; PARSIFAL Steering Committee and Trial Investigators. Fulvestrant-Palbociclib vs Letrozole-Palbociclib as Initial Therapy for Endocrine-Sensitive, Hormone Receptor-Positive, ERBB2-Negative Advanced Breast Cancer: A Randomized Clinical Trial. JAMA Oncol. 2021 Dec 1;7(12):1791-1799. doi: 10.1001/jamaoncol.2021.4301.

  PMID: 34617955 DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Interventions

palbociclib; Fulvestrant; Letrozole

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Estradiol; Estrenes; Estranes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Estradiol Congeners; Gonadal Steroid Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Nitriles; Organic Chemicals; Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Limitations and Caveats

The number of deaths was not sufficient to determine the secondary objective of calculating Overall Survival, so this value could not be obtained. We consider the fact that we were not able to obtain this factor to be very positive.

Results Point of Contact

• Title: Alicia Garcia
• Organization: MedSIR

alicia.garcia@medsir.org

+34 611261467

Study Officials

• Antonio Llombart, MD

  MedSIR

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 29, 2015
• First Posted: July 8, 2015
• Study Start: August 1, 2015
• Primary Completion: January 1, 2020
• Study Completion: January 1, 2020
• Last Updated: December 9, 2024
• Results First Posted: December 9, 2024

Record last verified: 2024-10

Locations

FR (5); ES (18); CZ (3); RU (4); GB (7); IT (9); DE (2)