Study 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.
Eligible Conditions
- HER2-positive Breast Cancer
- Estrogen Receptor Positive Breast Cancer
Treatment Effectiveness
Effectiveness Progress
This is further along than 85% of similar trials
Study Objectives
1 Primary · 7 Secondary · Reporting Duration: 24 months
24 months
3 and 5 year survival probabilities
Clinical Benefit Rate (CBR: CR or PR or SD ≥ 24 weeks
Duration of Response (DOR)
Objective Response Rate (OR: CR or PRR)
Overall Survival (OS)
Patient Reported Outcomes
Progression-free survival (PFS) as assessed by Investigator
Safety: Type incidence and severity (as graded by NCI CTCAE v 4.0)
Baseline
Genes
Month 24
PIK3CA genotype assessed in circulating cfDNA
Day 22
Trough Plasma concentration of palbociclib, trastuzumab and pertuzumab
Trial Safety
Safety Progress
This is further along than 85% of similar trials
Side Effects for
A: Letrozole
41%Fatigue
40%Hot flush
26%Arthralgia
21%Headache
18%Nausea
14%Diarrhoea
12%Breast pain
11%Myalgia
11%Hypertension
10%Depression
10%Constipation
9%Pain in extremity
8%Dizziness
8%Back pain
7%Dyspepsia
7%Contusion
7%Insomnia
7%Alanine aminotransferase increased
7%Upper respiratory tract infection
6%Blood alkaline phosphatase increased
5%Urinary tract infection
5%Procedural pain
4%Decreased appetite
4%Vomiting
4%Dyspnoea
4%Dry skin
3%Aspartate aminotransferase increased
3%Anaemia
3%Alopecia
3%Cough
2%Pruritus
2%Rash
2%Epistaxis
2%Neutrophil count decreased
2%Oropharyngeal pain
1%Skin infection
1%Hyperglycaemia
1%White blood cell count decreased
1%Oral pain
Trial Design
2 Treatment Groups
Arm B
1 of 2
Arm A
1 of 2
Active Control
Experimental Treatment
496 Total Participants · 2 Treatment Groups
Primary Treatment: palbociclib · No Placebo Group · Phase 3
Arm AExperimental Group · 7 Interventions: letrozole, Exemestane, pertuzumab, Anastrozole, Fulvestrant, trastuzumab, palbociclib · Intervention Types: Drug, Drug, Drug, Drug, Drug, Drug, Drug
Arm BActiveComparator Group · 5 Interventions: letrozole, Exemestane, pertuzumab, Anastrozole, Fulvestrant · Intervention Types: Drug, Drug, Drug, Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Letrozole
FDA approved
Exemestane
FDA approved
Pertuzumab
FDA approved
Anastrozole
FDA approved
Fulvestrant
FDA approved
Trastuzumab
FDA approved
Palbociclib
FDA approved
Trial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 24 months
Who is running the clinical trial?
Alliance Foundation Trials, LLC.Lead Sponsor
22 Previous Clinical Trials
24,657 Total Patients Enrolled
PrECOG, LLC.OTHER
17 Previous Clinical Trials
7,228 Total Patients Enrolled
SOLTI Breast Cancer Research GroupOTHER
37 Previous Clinical Trials
5,821 Total Patients Enrolled
2 Trials studying HER2-positive Breast Cancer
90 Patients Enrolled for HER2-positive Breast Cancer
Fondazione MichelangeloOTHER
9 Previous Clinical Trials
2,180 Total Patients Enrolled
UNICANCEROTHER
212 Previous Clinical Trials
279,750 Total Patients Enrolled
PfizerIndustry Sponsor
4,308 Previous Clinical Trials
7,110,339 Total Patients Enrolled
4 Trials studying HER2-positive Breast Cancer
246 Patients Enrolled for HER2-positive Breast Cancer
Syneos HealthOTHER
161 Previous Clinical Trials
69,420 Total Patients Enrolled
German Breast GroupOTHER
50 Previous Clinical Trials
46,613 Total Patients Enrolled
1 Trials studying HER2-positive Breast Cancer
170 Patients Enrolled for HER2-positive Breast Cancer
Breast Cancer Trials, Australia and New ZealandOTHER
4 Previous Clinical Trials
3,203 Total Patients Enrolled
1 Trials studying HER2-positive Breast Cancer
50 Patients Enrolled for HER2-positive Breast Cancer
Eligibility Criteria
Age 18+ · All Participants · 10 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:The inclusion criteria for this test are as follows: You are 18 years or older.
You are willing to provide a representative tumor specimen obtained from recently biopsied metastatic disease if clinically feasible
You have provided informed consent prior to any study specific assessments and procedures.
You have signed a Preliminary Screening Informed Consent Form prior to any study specific assessments and procedures.
Patients must have histologically confirmed HER2+ and hormone receptor positive (ER+ and/or PR+), metastatic breast cancer.
You have histologically confirmed invasive breast cancer that is metastatic or not amenable for resection or radiation therapy with curative intent.
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