Palbociclib for Malignant Neoplasms

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Malignant Neoplasms+1 More
Palbociclib - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial is testing if any of these combinations can help treat breast cancer.

Eligible Conditions
  • Malignant Neoplasms

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 2 Secondary · Reporting Duration: 2 years

2 years
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability)
Overall Response Rate
Progression Free Survival

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Side Effects for

Palbociclib + Fulvestrant
61%Neutropenia
38%Fatigue
29%Nausea
27%White blood cell count decreased
26%Anaemia
21%Headache
21%Neutrophil count decreased
20%Leukopenia
19%Diarrhoea
17%Constipation
15%Hot flush
15%Alopecia
14%Vomiting
13%Cough
13%Decreased appetite
13%Arthralgia
12%Thrombocytopenia
12%Stomatitis
11%Dyspnoea
11%Dizziness
11%Back pain
10%Pain in extremity
9%Oropharyngeal pain
9%Rash
8%Platelet count decreased
8%Insomnia
8%Pyrexia
7%Nasopharyngitis
7%Myalgia
7%Dyspepsia
7%Asthenia
7%Oedema peripheral
6%Aspartate aminotransferase increased
6%Dysgeusia
6%Abdominal pain
6%Dry mouth
6%Muscle spasms
6%Injection site pain
6%Musculoskeletal pain
6%Pruritus
6%Upper respiratory tract infection
6%Epistaxis
5%Depression
4%Anxiety
4%Pain
3%Musculoskeletal chest pain
3%Abdominal pain upper
2%Chest pain
1%Pulmonary embolism
1%Disease progression
This histogram enumerates side effects from a completed 2022 Phase 3 trial (NCT01942135) in the Palbociclib + Fulvestrant ARM group. Side effects include: Neutropenia with 61%, Fatigue with 38%, Nausea with 29%, White blood cell count decreased with 27%, Anaemia with 26%.

Trial Design

3 Treatment Groups

Fulvestrant
1 of 3
Fulvestrant with Palbociclib
1 of 3
Fulvestrant with Palbociclib and Avelumab
1 of 3

Active Control

Experimental Treatment

220 Total Participants · 3 Treatment Groups

Primary Treatment: Palbociclib · No Placebo Group · Phase 2

Fulvestrant with PalbociclibExperimental Group · 2 Interventions: Palbociclib, Fulvestrant · Intervention Types: Drug, Drug
Fulvestrant with Palbociclib and AvelumabExperimental Group · 3 Interventions: Palbociclib, Avelumab, Fulvestrant · Intervention Types: Drug, Drug, Drug
Fulvestrant
Drug
ActiveComparator Group · 1 Intervention: Fulvestrant · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Palbociclib
FDA approved
Avelumab
FDA approved
Fulvestrant
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 2 years

Who is running the clinical trial?

Dana-Farber Cancer InstituteLead Sponsor
1,014 Previous Clinical Trials
394,124 Total Patients Enrolled
PfizerIndustry Sponsor
4,264 Previous Clinical Trials
7,108,242 Total Patients Enrolled
Erica L Mayer, MD MPHPrincipal InvestigatorDana-Farber Cancer Institute

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
Children aged <18 years are excluded from this study.
It is not mandatory to have a CDK 4/6 inhibitor containing regimen as the most recent treatment.
You have 0-1 prior lines of cytotoxic chemotherapy in the metastatic setting.
You have histologically confirmed hormone receptor positive (HR+) HER2 negative metastatic or locally recurrent unresectable invasive breast cancer.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 13th, 2021

Last Reviewed: November 22nd, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.