← Back to Search

CDK4/6 Inhibitor

Targeted Therapy for Metastatic Breast Cancer (PATINA Trial)

Phase 3
Waitlist Available
Research Sponsored by Alliance Foundation Trials, LLC.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients must have histologically confirmed HER2+ and hormone receptor positive (ER+ and/or PR+), metastatic breast cancer. ER, PR and HER2 measurements should be performed according to institutional guidelines, in a CLIA-approved setting in the US or certified laboratories for Non-US regions. Cut-off values for positive/negative staining should be in accordance with current ASCO/CAP (American Society of Clinical Oncology/College of American Pathologists) guidelines.
Patients must agree to provide a representative formalin-fixed paraffin-embedded (FFPE) tumor tissue block (preferred) from primary breast or metastatic site (archival) OR at least 15 freshly cut unstained slides from such a block, along with a pathology report documenting HER2 positivity and hormone receptor positivity.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 months
Awards & highlights
No Placebo-Only Group
Pivotal Trial

Summary

This trial is testing whether adding a new drug to standard treatment can improve outcomes for people with hormone receptor-positive, HER2+ metastatic breast cancer.

Who is the study for?
This trial is for adults over 18 with hormone receptor-positive, HER2+ metastatic breast cancer that can't be removed by surgery or treated with radiation. Participants must have confirmed invasive breast cancer and agree to provide tumor tissue samples. It's not suitable for those who don't meet these specific cancer criteria.
What is being tested?
The study tests if adding palbociclib to anti-HER2 therapy and endocrine therapy (like Anastrozole, Fulvestrant) improves outcomes in patients compared to just anti-HER2 therapy plus endocrine treatment alone.
What are the potential side effects?
Palbociclib may cause low white blood cell counts leading to infection risk, fatigue, nausea, hair thinning, rash, vomiting and diarrhea. Anti-HER2 drugs can cause heart problems and allergic reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My breast cancer is confirmed to be HER2+, ER+, or PR+ and metastatic.
Select...
I agree to provide a tissue sample from my cancer for testing.
Select...
I am 18 years old or older.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Secondary study objectives
3 and 5 year survival probabilities
Clinical Benefit Rate (CBR: CR or PR or SD ≥ 24 weeks
Duration of Response (DOR)
+5 more
Other study objectives
PIK3CA genotype assessed in circulating cfDNA
Trough Plasma concentration of palbociclib, trastuzumab and pertuzumab
Genes

Side effects data

From 2019 Phase 2 trial • 307 Patients • NCT02296801
41%
Fatigue
40%
Hot flush
26%
Arthralgia
21%
Headache
18%
Nausea
14%
Diarrhoea
12%
Breast pain
11%
Myalgia
11%
Hypertension
10%
Constipation
10%
Depression
9%
Pain in extremity
8%
Dizziness
8%
Back pain
7%
Dyspepsia
7%
Alanine aminotransferase increased
7%
Upper respiratory tract infection
7%
Contusion
7%
Insomnia
6%
Blood alkaline phosphatase increased
5%
Procedural pain
5%
Urinary tract infection
4%
Vomiting
4%
Decreased appetite
4%
Dyspnoea
4%
Dry skin
3%
Anaemia
3%
Aspartate aminotransferase increased
3%
Cough
3%
Alopecia
2%
Neutrophil count decreased
2%
Epistaxis
2%
Pruritus
2%
Oropharyngeal pain
2%
Rash
1%
Skin infection
1%
Hyperglycaemia
1%
Oral pain
1%
White blood cell count decreased
100%
80%
60%
40%
20%
0%
Study treatment Arm
A: Letrozole
B+D+C Palbociclib + Letrozole Regimen

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Arm AExperimental Treatment7 Interventions
Palbociclib 125 mg daily + AntiHER2 Therapy (trastuzumab/pertuzumab) q3wks + Endocrine Therapy (letrozole, anastrozole, exemstane OR fulvestratnt) until confirmed disease progression
Group II: Arm BActive Control5 Interventions
AntiHER2 Therapy (trastuzumab/pertuzumab) q3wks + Endocrine Therapy (letrozole, anastrozole, exemstane OR fulvestrant) until confirmed disease progression
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
trastuzumab
2002
Completed Phase 3
~1790
Exemestane
2003
Completed Phase 4
~7510
pertuzumab
2013
Completed Phase 3
~1350
letrozole
1998
Completed Phase 3
~16660
Anastrozole
2016
Completed Phase 4
~5550
Fulvestrant
2011
Completed Phase 3
~3790
palbociclib
2020
Completed Phase 2
~1230

Find a Location

Who is running the clinical trial?

SOLTI Breast Cancer Research GroupOTHER
42 Previous Clinical Trials
7,427 Total Patients Enrolled
21 Trials studying Breast Cancer
2,307 Patients Enrolled for Breast Cancer
PrECOG, LLC.OTHER
18 Previous Clinical Trials
7,500 Total Patients Enrolled
1 Trials studying Breast Cancer
5,796 Patients Enrolled for Breast Cancer
UNICANCEROTHER
233 Previous Clinical Trials
309,340 Total Patients Enrolled
35 Trials studying Breast Cancer
33,740 Patients Enrolled for Breast Cancer
Syneos HealthOTHER
176 Previous Clinical Trials
68,159 Total Patients Enrolled
Breast Cancer Trials, Australia and New ZealandOTHER
5 Previous Clinical Trials
4,610 Total Patients Enrolled
4 Trials studying Breast Cancer
3,443 Patients Enrolled for Breast Cancer
Alliance Foundation Trials, LLC.Lead Sponsor
23 Previous Clinical Trials
24,540 Total Patients Enrolled
2 Trials studying Breast Cancer
5,799 Patients Enrolled for Breast Cancer
PfizerIndustry Sponsor
4,669 Previous Clinical Trials
17,861,428 Total Patients Enrolled
114 Trials studying Breast Cancer
41,343 Patients Enrolled for Breast Cancer
German Breast GroupOTHER
53 Previous Clinical Trials
47,927 Total Patients Enrolled
28 Trials studying Breast Cancer
36,572 Patients Enrolled for Breast Cancer
Fondazione MichelangeloOTHER
9 Previous Clinical Trials
2,180 Total Patients Enrolled
1 Trials studying Breast Cancer
632 Patients Enrolled for Breast Cancer

Media Library

Palbociclib (CDK4/6 Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT02947685 — Phase 3
Breast Cancer Research Study Groups: Arm A, Arm B
Breast Cancer Clinical Trial 2023: Palbociclib Highlights & Side Effects. Trial Name: NCT02947685 — Phase 3
Palbociclib (CDK4/6 Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02947685 — Phase 3
~58 spots leftby Dec 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top