Cisplatin for Breast Cancer

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Breast CancerCisplatin - Drug
Eligibility
18+
Female
What conditions do you have?
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Study Summary

This trial is testing if a certain kind of chemotherapy is more effective than another kind in treating a specific type of breast cancer.

Eligible Conditions
  • Breast Cancer

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 4 Secondary · Reporting Duration: Evaluated after definitive breast surgery, up to 4-5 months from enrollment.

Month 5
Number With Pathologic Complete Response (pCR) by HR-deficiency (HRD) Status
Number With Pathologic Response
Number of Participants With Pathologic Response by HR-deficiency (HRD) Status
Number of Pathologic Response
Positive Predictive Value (PPV) of HRD Score

Trial Safety

Safety Progress

2 of 3
This is further along than 68% 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

2 Treatment Groups

Arm B: Paclitaxel
1 of 2
Arm A: Cisplatin
1 of 2

Experimental Treatment

147 Total Participants · 2 Treatment Groups

Primary Treatment: Cisplatin · No Placebo Group · Phase 2

Arm B: Paclitaxel
Drug
Experimental Group · 1 Intervention: Paclitaxel · Intervention Types: Drug
Arm A: Cisplatin
Drug
Experimental Group · 1 Intervention: Cisplatin · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cisplatin
FDA approved
Paclitaxel
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: evaluated after definitive breast surgery, up to 4-5 months from enrollment.

Who is running the clinical trial?

Translational Breast Cancer Research ConsortiumOTHER
21 Previous Clinical Trials
2,141 Total Patients Enrolled
12 Trials studying Breast Cancer
1,493 Patients Enrolled for Breast Cancer
Dana-Farber Cancer InstituteLead Sponsor
1,016 Previous Clinical Trials
393,651 Total Patients Enrolled
135 Trials studying Breast Cancer
21,668 Patients Enrolled for Breast Cancer
Myriad Genetics, Inc.Industry Sponsor
15 Previous Clinical Trials
5,205 Total Patients Enrolled
2 Trials studying Breast Cancer
653 Patients Enrolled for Breast Cancer
Erica Mayer, MDPrincipal InvestigatorDana-Farber Cancer Institute
2 Previous Clinical Trials
5,851 Total Patients Enrolled
2 Trials studying Breast Cancer
5,851 Patients Enrolled for Breast Cancer

Eligibility Criteria

Age 18+ · Female Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
AJCC stage I invasive breast cancer with a tumor size larger than 1.
For patients who do not have any cancer in their axilla, their baseline assessment of the axilla will be done at the discretion of their doctor.
Pathologic documentation of invasive cancer by biopsy is necessary for accurate diagnosis.
: -written informed consent obtained -no significant medical problems To be eligible to participate in the study, participants must meet the following criteria on screening examination: written informed consent obtained, and no significant medical problems.
The study is open to people with multicentric or bilateral cancer if at least one lesion meets the stage eligibility criteria for the study, and no tumor is HER2-positive.
You do not need to know your BRCA1/2 status to participate in this study, but patients with a known deleterious BRCA1/2 mutation should be encouraged to consider a preoperative trial specifically designed for BRCA1/2 carriers, if available.
For people with a positive result from a physical examination of their lymph nodes, their doctor may recommend a needle aspiration, core biopsy, or SLN procedure to determine if the lymph nodes contain cancerous cells.
For patients who have pathologically positive axillary lymph nodes prior to preoperative therapy, it is recommended that a level I and II lymph node dissection be done at the time of definitive surgery.
Tumors that are classified as HER2 negative are defined as those that have a score of 0 or 1+ on an immunohistochemistry assay, and/or lack of gene amplification by fluorescence in situ hybridization (FISH), with a ratio of < 2 on invasive tumor by local review.
The status of a tumor's estrogen receptor (ER) and progesterone receptor (PgR) by immunohistochemistry (IHC) must be known