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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

PATINA 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.Check my eligibility

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.See study design

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.

PATINA Trial 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.

PATINA Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 24 months

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Progression-free survival (PFS) as assessed by Investigator

Secondary outcome measures

3 and 5 year survival probabilities

Clinical Benefit Rate (CBR: CR or PR or SD ≥ 24 weeks

Duration of Response (DOR)

+5 more

Other outcome measures

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%

Depression

10%

Constipation

Pain in extremity

Back pain

Dizziness

Upper respiratory tract infection

Insomnia

Dyspepsia

Contusion

Alanine aminotransferase increased

Blood alkaline phosphatase increased

Procedural pain

Urinary tract infection

Decreased appetite

Vomiting

Dyspnoea

Dry skin

Aspartate aminotransferase increased

Anaemia

Cough

Alopecia

Neutrophil count decreased

Epistaxis

Oropharyngeal pain

Pruritus

Rash

Skin infection

White blood cell count decreased

Oral pain

Hyperglycaemia

100%

80%

60%

40%

20%

Study treatment Arm

A: Letrozole

B+D+C Palbociclib + Letrozole Regimen

PATINA 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

letrozole

1998

Completed Phase 3

~16660

pertuzumab

2013

Completed Phase 3

~1350

trastuzumab

2002

Completed Phase 3

~1790

Exemestane

2003

Completed Phase 4

~7880

Anastrozole

2019

Completed Phase 4

~10090

Fulvestrant

2011

Completed Phase 3

~3690

palbociclib

2020

Completed Phase 2

~1230

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

SOLTI Breast Cancer Research GroupOTHER

41 Previous Clinical Trials

7,178 Total Patients Enrolled

21 Trials studying Breast Cancer

2,307 Patients Enrolled for Breast Cancer

PrECOG, LLC.OTHER

17 Previous Clinical Trials

6,962 Total Patients Enrolled

1 Trials studying Breast Cancer

5,796 Patients Enrolled for Breast Cancer

UNICANCEROTHER

221 Previous Clinical Trials

282,390 Total Patients Enrolled

35 Trials studying Breast Cancer

33,745 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Palbociclib is frequently given to patients for what reason?

"Palbociclib is most often given to patients to help prevent disease progression. However, it is also used to treat other conditions like high risk of recurrence and tamoxifen."

Answered by AI

Are there any potential risks to taking palbociclib?

"Palbociclib's safety has been well-documented in prior Phase 3 clinical trials, and so it received a score of 3 from our analysts."

Answered by AI

Are there different sites in the US where this clinical trial is being conducted?

"Currently, there are 38 medical facilities running this trial; some notable hospitals include Legacy Good Samaritan Hospital in Portland, The University of Chicago Medical Center in Chicago, and UCSF in San Francisco."

Answered by AI

What are the most recent findings regarding palbociclib's efficacy?

"There are currently 543 ongoing clinical trials researching palbociclib, with 131 of those in Phase 3. Although a significant amount of the research is being conducted in Seattle, WA, there are 34249 different locations running studies on palbociclib."

Answered by AI

Can new participants still sign up for this research project?

"Unfortunately, this particular clinical trial is no longer active and has not been since March 16th, 2022. It was originally posted on June 21st, 2017. However, there are 2,900 other trials that are actively recruiting patients right now."

Answered by AI

Recent research and studies

The LancetJournal

Comparisons Between Different Polychemotherapy Regimens for Early Breast Cancer: Meta-analyses of Long-term Outcome Among 100 000 Women in 123 Randomised Trials

Early Breast Cancer Trialists' Collaborative Group (EBCTCG). 2012. “Comparisons Between Different Polychemotherapy Regimens for Early Breast Cancer: Meta-analyses of Long-term Outcome Among 100 000 Women in 123 Randomised Trials”. The Lancet. Elsevier BV. doi:10.1016/s0140-6736(11)61625-5.

New England Journal of MedicineJournal

Trends in Metastatic Breast and Prostate Cancer — Lessons in Cancer Dynamics

Welch, H. Gilbert, David H. Gorski, and Peter C. Albertsen. 2015. “Trends in Metastatic Breast and Prostate Cancer — Lessons in Cancer Dynamics”. New England Journal of Medicine. Massachusetts Medical Society. doi:10.1056/nejmp1510443.

CellJournal

The P21 Cdk-interacting Protein Cip1 Is a Potent Inhibitor of G1 Cyclin-dependent Kinases

Wade Harper, J. 1993. “The P21 Cdk-interacting Protein Cip1 Is a Potent Inhibitor of G1 Cyclin-dependent Kinases”. Cell. Elsevier BV. doi:10.1016/0092-8674(93)90499-g.

Genes & DevelopmentJournal