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CDK4/6 Inhibitor

Palbociclib PD-0332991 for Breast Cancer (PENELOPE-B Trial)

Phase 3
Waitlist Available
Led By Gunter von Minckwitz, MD, Prof
Research Sponsored by German Breast Group
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from date of randomisation to data cut off: 24 august 2020 (approximately 6 years and 6 months)
Awards & highlights

PENELOPE-B Trial Summary

This trial is testing whether a drug called palbociclib is better than placebo at preventing the return of breast cancer in women who have had neoadjuvant chemotherapy.

Eligible Conditions
  • Breast Cancer
  • No change needed.
  • Postneoadjuvant Treatment
  • End-Stage Liver Disease

PENELOPE-B Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from date of randomisation to data cut off: 24 august 2020 (approximately 6 years and 6 months)
This trial's timeline: 3 weeks for screening, Varies for treatment, and from date of randomisation to data cut off: 24 august 2020 (approximately 6 years and 6 months) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Invasive Disease Free Survival (iDFS) for Palbociclib vs. Placebo in Patients With High CPS-EG Score After Neoadjuvant Chemotherapy Receiving Standard Adjuvant Endocrine Therapy for HR-positive/HER2-normal Primary Breast Cancer.
Secondary outcome measures
Distant Disease Free Survival (DDFS)
Overall Survival (OS)
iDFS Excluding Second Non-breast Cancers
Other outcome measures
Scores and markers for their prognostic value in this specific trial setting and their predictive information on the efficacy and/or safety of palbociclib

Side effects data

From 2020 Phase 3 trial • 1250 Patients • NCT01864746
99%
Leukopenia
96%
Neutropenia
74%
Anemia
66%
Fatigue
60%
Infection
57%
Thrombocytopenia
44%
Hot flush
41%
Arthralgia
35%
Hypocalcemia
29%
Hypomagnesemia
28%
Other skin and subcutaneous tissue disorders
27%
Stomatitis
24%
Nausea
23%
Headache
23%
Other gastrointestinal disorders
22%
Constipation
22%
Alanine aminotransferase increased
21%
Aspartate aminotransferase increased
21%
Cough
21%
Other nervous system disorders
20%
Peripheral edema
20%
Myalgia
19%
Other nusculoskeletal, connective tissue and bone disorders
18%
Diarrhea
17%
Blood alkaline phosphatase increased
17%
Bone pain
12%
Dyspnea
12%
Blood creatinine increased
11%
Pyrexia
11%
Hyperkalemia
10%
Vomiting
10%
Blood albumin decreased
9%
Hypernatremia
9%
Hypertension
8%
Decreased appetite
8%
Vaginal dryness
8%
Hypokalemia
7%
Vertigo
7%
Blood bilirubin increased
7%
Hyponatremia
6%
Dysgeusia
6%
Epistaxis
3%
Hypercalcemia
3%
Febrile neutropenia
3%
Abdominal distension
3%
Infections and infestations
2%
Vaginal hemorrhage
2%
Embolism
2%
Glucose tolerance impaired
2%
Injury, poisoning and procedural complications
1%
Cataract
1%
Cellulitis
1%
Blood and the lymphatic system disorders
1%
Overdose
1%
Vascular disorders
100%
80%
60%
40%
20%
0%
Study treatment Arm
Palbociclib
Placebo

PENELOPE-B Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: PalbociclibExperimental Treatment1 Intervention
Palbociclib at a dose of 125 mg once daily, day 1 to day 21 followed by 7 days off treatment in a 28-day cycle for thirteen cycles
Group II: PlaceboPlacebo Group1 Intervention
Placebo of palbociclib once daily day 1 to day 21 followed by 7 days off treatment in a28-day cycle for thirteen cycles
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Palbociclib PD-0332991
2013
Completed Phase 3
~1250

Find a Location

Who is running the clinical trial?

German Breast GroupLead Sponsor
52 Previous Clinical Trials
47,073 Total Patients Enrolled
27 Trials studying Breast Cancer
35,322 Patients Enrolled for Breast Cancer
PfizerIndustry Sponsor
4,582 Previous Clinical Trials
14,633,547 Total Patients Enrolled
112 Trials studying Breast Cancer
34,797 Patients Enrolled for Breast Cancer
AGO Study GroupOTHER
30 Previous Clinical Trials
14,493 Total Patients Enrolled
2 Trials studying Breast Cancer
2,830 Patients Enrolled for Breast Cancer

Media Library

Palbociclib PD-0332991 (CDK4/6 Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT01864746 — Phase 3
Breast Cancer Research Study Groups: Palbociclib, Placebo
Breast Cancer Clinical Trial 2023: Palbociclib PD-0332991 Highlights & Side Effects. Trial Name: NCT01864746 — Phase 3
Palbociclib PD-0332991 (CDK4/6 Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT01864746 — Phase 3
~108 spots leftby May 2025
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