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

Metastatic Breast Cancer Clinical Trial

— PARSIFAL  

Official title:

A Randomized, Multicenter, Open-label, Phase II Trial to Evaluate the Efficacy and Safety of Palbociclib in Combination With Fulvestrant or Letrozole in Patients With HER2 Negative, ER+ Metastatic Breast Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02491983
• Other study ID #: MedOPP067
• Secondary ID: 2014-004698-17
• Status: Completed
• Phase: Phase 2
• Start date: August 2015
• Est. completion date: January 2020

Study information

• Verified date: June 2022
• Source: MedSIR
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Patients will be stratified by site of disease (visceral vs. non-visceral) and by onset of metastatic disease diagnose (patients metastatic de novo versus non de novo).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 486
• Est. completion date: January 2020
• Est. primary completion date: January 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Women 18 years or older with metastatic or locally advanced disease, not amenable to curative therapy

2. Confirmed diagnosis of HR+/HER2- breast cancer

3. Post-menopausal status

4. No prior chemotherapy line in the metastatic setting

5. Measurable disease defined by RECIST version 1.1, or non-measurable disease

6. Eastern Cooperative Oncology Group (ECOG) PS 0-1

7. Adequate organ and marrow function, resolution of all toxic effects of prior therapy or surgical procedures

8. 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

Exclusion Criteria:

1. ER or HER2 unknown disease

2. HER2 positive disease based on local laboratory results

3. Locally advanced breast cancer candidate for a radical treatment

4. Prior (neo)adjuvant endocrine treatment with DFI = 12-months from completion of treatment.

5. Patients with rapidly progressive visceral disease or visceral crisis.

6. Major surgery within 4 weeks of start of study drug

7. Patients with an active, bleeding diathesis

8. Serious concomitant systemic disorder incompatible with the study

9. Are unable to swallow tablets

10. Chronic daily treatment with corticosteroids with a dose of = 10mg/day methylprednisolone equivalent

11. Known active uncontrolled or symptomatic CNS metastases

12. Known hypersensitivity to letrozole, fulvestrant or any of their excipients, or to any PD-0332991 excipients

13. 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

14. Uncontrolled electrolyte disorders that can compound the effects of a QTc-prolonging drug

Related Conditions & MeSH terms

• Breast Neoplasms
• Metastatic Breast Cancer

Intervention

Drug:
• Palbociclib

• Fulvestrant

• Letrozole

Locations

Country	Name	City	State
Czechia	MedSIR investigative site	Olomouc
Czechia	MedSIR investigative site	Prague
Czechia	MedSIR investigative site	Prague
France	MedSIR investigative site	Paris
France	MedSIR investigative site	Paris
France	MedSIR investigative site	Paris
France	MedSIR investigative site	Strasbourg
France	MedSIR investigative site	Toulouse
Germany	MedSIR investigative site	Dessau
Germany	MedSIR investigative site	Heidelberg
Italy	MedSIR investigative site	Brindisi
Italy	MedSIR investigative site	Cagliari
Italy	MedSIR investigative site	Cremona
Italy	MedSIR investigative site	Milan
Italy	MedSIR investigative site	Milan
Italy	MedSIR investigative site	Modena
Italy	MedSIR investigative site	Monza
Italy	MedSIR investigative site	Piacenza
Italy	MedSIR investigative site	Torino
Russian Federation	MedSIR investigative site	Moscow
Russian Federation	MedSIR investigative site	Moscow
Russian Federation	MedSIR investigative site	Saint Petersburg
Russian Federation	MedSIR investigative site	Yaroslavl
Spain	MedSIR investigative site	Barcelona
Spain	MedSIR investigative site	Barcelona
Spain	MedSIR investigative site	Barcelona
Spain	MedSIR investigative site	Bilbao
Spain	MedSIR investigative site	Cáceres
Spain	MedSIR investigative site	Castelló
Spain	MedSIR investigative site	Cordoba
Spain	MedSIR investigative site	Girona
Spain	MedSIR investigative site	Huelva
Spain	MedSIR investigative site	Madrid
Spain	MedSIR investigative site	Oviedo
Spain	MedSIR investigative site	Pamplona
Spain	MedSIR investigative site	Santiago de Compostela
Spain	MedSIR investigative site	Sevilla
Spain	MedSIR investigative site	Tarragona
Spain	MedSIR investigative site	Valencia
Spain	MedSIR investigative site	Zaragoza
Spain	MedSIR investigative site B	Zaragoza
United Kingdom	MedSIR investigative site	Bath
United Kingdom	MedSIR investigative site	London
United Kingdom	MedSIR investigative site	Manchester
United Kingdom	MedSIR investigative site	Nottingham
United Kingdom	MedSIR investigative site	Romford
United Kingdom	MedSIR investigative site	Swansea
United Kingdom	MedSIR investigative site	Truro

Sponsors (1)

Lead Sponsor	Collaborator
MedSIR

Countries where clinical trial is conducted

Czechia,  France,  Germany,  Italy,  Russian Federation,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	1-year Progression Free Survival	Percentage of patients who are alive and without evidence of tumor progression at 52 weeks of study entry.	Baseline up to 52 weeks after last patient entry
Secondary	Grade 3/4 adverse events, SAEs, deaths and discontinuations •	CTCAE v5	Baseline up to 52 weeks after last patient entry
Secondary	Time To Progression (TTP)	Time from randomization to disease progression	Baseline up to 52 weeks after last patient entry
Secondary	Overall Survival (OS)	Time from date of randomization to date of death due to any cause	Baseline up to 52 weeks after last patient entry
Secondary	Clinical Benefit Rate	Percentage of patients who experience a CR, PR or stable disease (for at least 24 weeks) and assessed by modified Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) criteria.	Baseline up to 52 weeks after last patient entry
Secondary	Overall Response Rate	proportion of patients with best overall response of confirmed complete response (CR) or partial response (PR) based on local investigator's assessment according to RECIST criteria guidelines (version 1.1)	Baseline up to 52 weeks after last patient entry