← 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 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

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

Pain in extremity

Dizziness

Back pain

Dyspepsia

Alanine aminotransferase increased

Upper respiratory tract infection

Contusion

Insomnia

Blood alkaline phosphatase increased

Procedural pain

Urinary tract infection

Vomiting

Decreased appetite

Dyspnoea

Dry skin

Anaemia

Aspartate aminotransferase increased

Cough

Alopecia

Neutrophil count decreased

Epistaxis

Pruritus

Oropharyngeal pain

Rash

Skin infection

Hyperglycaemia

Oral pain

White blood cell count decreased

100%

80%

60%

40%

20%

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