Capecitabine for Triple Negative Breast Cancer

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
Triple Negative Breast Cancer+11 MoreCapecitabine - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial is comparing two types of chemotherapy drugs to see which is more effective in treating patients with residual triple negative basal-like breast cancer.

Eligible Conditions
  • Triple Negative Breast Cancer
  • Progesterone Receptor Negative Breast Cancer
  • Breast Cancer, Stage III
  • Stage IIIA Breast Cancer
  • HER2/Neu Negative Breast Cancer
  • Breast Cancer
  • Breast Cancer, Stage II
  • Stage IIA Breast Cancer
  • Stage IIB Breast Cancer
  • Breast Cancer Stage IIIc
  • Estrogen Receptor Negative Breast Cancer
  • Breast Cancer, Stage IIIB

Treatment Effectiveness

Effectiveness Progress

2 of 3
This is further along than 85% of similar trials

Study Objectives

2 Primary · 10 Secondary · Reporting Duration: Assessed at 6 months after randomization

Month 15
Health-related Quality of Life (HRQL) at 15-month Assessment
Month 6
Health-related Quality of Life (HRQL) at 6-month Assessment
Assessed at registration to step 0 (baseline)
Proportion of Basal Subtype
Year 3
3-year Overall Survival (OS) Rate in Basal-Subtype Patients
Baseline
Activation Analysis
Month 86
Invasive disease-free survival (IDFS) of patients with basal-like triple-negative breast cancer (TNBC)
Year 3
3-year Invasive Disease-Free Survival (IDFS) Rate in Basal-Subtype Patients
3-year Recurrence-Free Survival (RFS) Rate in Basal-Subtype Patients
Month 116
Overall survival (OS) of patients with basal-like triple-negative breast cancer (TNBC) with residual disease after neoadjuvant chemotherapy
Up to 15 months
Patient reported outcome (PRO)
Month 86
Incidence of toxicity graded using the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0
Recurrence-free survival (RFS)

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Side Effects for

Gemcitabine Plus Cisplatin (GC)
51%Neutropenia
47%Leukopenia
46%Nausea
43%Vomiting
35%Anaemia
31%Decreased appetite
26%Haemoglobin decreased
26%Fatigue
25%Constipation
25%White blood cell count decreased
24%Neutrophil count decreased
19%Alanine aminotransferase increased
13%Platelet count decreased
12%Rash
10%Thrombocytopenia
10%Aspartate aminotransferase increased
9%Blood sodium decreased
8%Hypokalaemia
7%Pyrexia
7%Insomnia
6%Cough
6%Hyponatraemia
6%Lymphopenia
6%Blood creatinine increased
6%Diarrhoea
6%Dyspepsia
6%Red blood cell count decreased
4%Dizziness
2%Bone marrow failure
1%Dyspnoea
1%Pulmonary embolism
1%Superior vena cava syndrome
1%Cerebral infarction
1%Embolism venous
1%Ischaemic stroke
This histogram enumerates side effects from a completed 2012 Phase 3 trial (NCT01005680) in the Gemcitabine Plus Cisplatin (GC) ARM group. Side effects include: Neutropenia with 51%, Leukopenia with 47%, Nausea with 46%, Vomiting with 43%, Anaemia with 35%.

Trial Design

3 Treatment Groups

Arm A (observation) (closed to accrual 05/16/2016)
1 of 3
Arm C (capecitabine)
1 of 3
Arm B (cisplatin or carboplatin)
1 of 3

Active Control

Experimental Treatment

415 Total Participants · 3 Treatment Groups

Primary Treatment: Capecitabine · No Placebo Group · Phase 3

Arm B (cisplatin or carboplatin)Experimental Group · 5 Interventions: Laboratory Biomarker Analysis, Carboplatin, Cisplatin, Quality-of-Life Assessment, Questionnaire Administration · Intervention Types: Other, Drug, Drug, Procedure, Other
Arm A (observation) (closed to accrual 05/16/2016)NoIntervention Group · 3 Interventions: Laboratory Biomarker Analysis, Quality-of-Life Assessment, Questionnaire Administration · Intervention Types: Other, Procedure, Other
Arm C (capecitabine)ActiveComparator Group · 4 Interventions: Laboratory Biomarker Analysis, Capecitabine, Quality-of-Life Assessment, Questionnaire Administration · Intervention Types: Other, Drug, Procedure, Other
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Carboplatin
FDA approved
Cisplatin
FDA approved
Quality-of-Life Assessment
2016
Completed Phase 3
~7220

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: assessed at 6 months after randomization

Who is running the clinical trial?

ECOG-ACRIN Cancer Research GroupLead Sponsor
104 Previous Clinical Trials
171,816 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,098 Previous Clinical Trials
41,145,442 Total Patients Enrolled
Ingrid MayerPrincipal InvestigatorECOG-ACRIN Cancer Research Group
2 Previous Clinical Trials
142 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have clinical stage II-III breast cancer at diagnosis, based on initial evaluation by clinical examination and/or breast imaging
You have >10% cells that stain positive, with weak intensity score (equivalent to Allred score =< 3).
You have > 1% cells with weak or intermediate intensity score (equivalent to Allred score =< 3).
Patients must have completed neoadjuvant taxane +/- anthracycline; patients must NOT have received cisplatin or carboplatin or capecitabine as part of their neoadjuvant therapy regimen.
You are eligible for screening and/or molecular testing if you are aged 18 years or older.