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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 weeks3 visits
Treatment ~ Varies
Follow Up ~ from date of randomisation to data cut off: 24 august 2020 (approximately 6 years and 6 months)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from date of randomisation to data cut off: 24 august 2020 (approximately 6 years and 6 months)
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 • NCT0186474699%
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%
Other nervous system disorders
21%
Cough
20%
Myalgia
20%
Peripheral edema
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%
Hyperkalemia
11%
Pyrexia
10%
Vomiting
10%
Blood albumin decreased
9%
Hypernatremia
9%
Hypertension
8%
Vaginal dryness
8%
Hypokalemia
8%
Decreased appetite
7%
Hyponatremia
7%
Blood bilirubin increased
7%
Vertigo
6%
Epistaxis
6%
Dysgeusia
3%
Hypercalcemia
3%
Infections and infestations
3%
Febrile neutropenia
3%
Abdominal distension
2%
Embolism
2%
Glucose tolerance impaired
2%
Vaginal hemorrhage
2%
Injury, poisoning and procedural complications
1%
Vascular disorders
1%
Cellulitis
1%
Cataract
1%
Blood and the lymphatic system disorders
1%
Overdose
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
4,567 Previous Clinical Trials
10,910,623 Total Patients Enrolled
110 Trials studying Breast Cancer
35,154 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
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have shown suicidal behavior or thoughts in the past year or are currently experiencing them.You have received treatment with a specific type of medication called CDK4/6 inhibitor in the past.You have had severe allergic reactions to drugs similar to palbociclib or to the ingredients in palbociclib or placebo medications.
Research Study Groups:
This trial has the following groups:- Group 1: Palbociclib
- Group 2: Placebo
Awards:
This trial has 1 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the total sample size for this experiment?
"This study has completed recruitment for participants. It was originally posted on November 1st, 2013 and most recently updated on April 11th, 2022. However, if you are still seeking to participate in clinical trials, there are 2695 studies actively looking for patients with breast cancer and 139 studies for Palbociclib PD-0332991 enrolling new participants."
Answered by AI
What is the general purpose of Palbociclib PD-0332991?
"Palbociclib PD-0332991 is most commonly used as a breast cancer treatment, however it has also been effective in managing malignant neoplasms, postmenopause, and advance directives."
Answered by AI
Are there any open slots for volunteers in this experiment?
"This particular trial is not recruiting patients at the moment, however there are 2695 other studies for breast cancer and 139 for Palbociclib PD-0332991 that are."
Answered by AI
Is Palbociclib PD-0332991 a viable treatment option for patients?
"As this is a Phase 3 trial, there is existing data to support the efficacy of Palbociclib PD-0332991. Furthermore, multiple rounds of testing have confirmed its safety, so it has been given a score of 3."
Answered by AI
Could you please provide more context on previous research done on Palbociclib PD-0332991?
"There are currently 139 clinical trials studying Palbociclib PD-0332991, with 17 of them being in Phase 3. Most of these trails are based in Burgas, New jersey; however, there are 6640 locations conducting clinical trials for Palbociclib PD-0332991."
Answered by AI
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