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Alkylating agents

Cisplatin for Breast Cancer

Phase 2

Waitlist Available

Led By Erica Mayer, MD

Research Sponsored by Dana-Farber Cancer Institute

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up evaluated after definitive breast surgery, up to 4-5 months from enrollment.

Awards & highlights

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

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ evaluated after definitive breast surgery, up to 4-5 months from enrollment.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~evaluated after definitive breast surgery, up to 4-5 months from enrollment.

This trial's timeline: 3 weeks for screening, Varies for treatment, and evaluated after definitive breast surgery, up to 4-5 months from enrollment. for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Number of Participants With Pathologic Response by HR-deficiency (HRD) Status

Secondary outcome measures

Number With Pathologic Complete Response (pCR) by HR-deficiency (HRD) Status

Number With Pathologic Response

Number of Pathologic Response

+1 more

Side effects data

From 2012 Phase 3 trial • 256 Patients • NCT01005680

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%

Aspartate aminotransferase increased

10%

Thrombocytopenia

Blood sodium decreased

Hypokalaemia

Insomnia

Pyrexia

Hyponatraemia

Blood creatinine increased

Lymphopenia

Diarrhoea

Dyspepsia

Red blood cell count decreased

Cough

Dizziness

Bone marrow failure

Ischaemic stroke

Cerebral infarction

Dyspnoea

Pulmonary embolism

Embolism venous

Superior vena cava syndrome

100%

80%

60%

40%

20%

Study treatment Arm

Gemcitabine Plus Cisplatin (GC)

Pemetrexed Plus Cisplatin (PC)

Trial Design

2Treatment groups

Experimental Treatment

Group I: Arm B: PaclitaxelExperimental Treatment1 Intervention

Paclitaxel given by IV infusion at a dose of 80 mg/m2 weekly for 12 weeks (4 cycles) as neoadjuvant chemotherapy. Participants with inadequate clinical response after 12 weeks (as judged either clinically or radiologically by a provider) were able to 'crossover' to an alternative provider-selected preoperative chemotherapy regimen. Definitive breast surgery following no later than 42 days after administration of last chemotherapy.

Group II: Arm A: CisplatinExperimental Treatment1 Intervention

Cisplatin given by IV infusion at a dose of 75 mg/m2 every 3 weeks (1 cycle) for 4 cycles as preoperative chemotherapy. Participants with inadequate clinical response after 12 weeks (as judged either clinically or radiologically by a provider) were able to crossover to an alternative provider-selected preoperative chemotherapy regimen. Definitive breast surgery following no later than 42 days after administration of last chemotherapy.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Cisplatin

2013

Completed Phase 3

~1940

Paclitaxel

2011

Completed Phase 4

~5380

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Dana-Farber Cancer InstituteLead Sponsor

1,079 Previous Clinical Trials

340,801 Total Patients Enrolled

142 Trials studying Breast Cancer

22,617 Patients Enrolled for Breast Cancer

Myriad Genetics, Inc.Industry Sponsor

16 Previous Clinical Trials

5,242 Total Patients Enrolled

2 Trials studying Breast Cancer

603 Patients Enrolled for Breast Cancer

Translational Breast Cancer Research ConsortiumOTHER

22 Previous Clinical Trials

2,210 Total Patients Enrolled

13 Trials studying Breast Cancer

1,575 Patients Enrolled for Breast Cancer

Frequently Asked Questions

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

Has research into Cisplatin been conducted prior to this?

"In 1997, the City of Hope Comprehensive Cancer Center first tested cisplatin. Since that time, 1942 clinical trials have been completed and 1333 are in progress around the world; many of these experiments are occurring near Indianapolis, Indiana."

Answered by AI

What conditions is Cisplatin typically used to treat?

"In addition to non-small cell lung carcinoma, Cisplatin is also used in the treatment of neoplasm metastasis, Kaposi's sarcoma, and other advanced directives."

Answered by AI

Has the FDA sanctioned Cisplatin for medicinal use?

"Based on the available safety data, Cisplatin was rated a 2 out of 3. This Phase 2 trial provides evidence for this medication's security but no indication of its efficacy yet."

Answered by AI

Are there currently any opportunities to participate in this research program?

"This trial is currently closed for recruitment. The initial announcement was made on April 1st, 2014 and the last update was recorded on February 14th, 2022. If you are seeking other studies related to breast cancer, there are 2351 trials actively recruiting with 1333 of those examining Cisplatin specifically."

Answered by AI

What is the cap on enrollment for this research endeavor?

"Unfortunately, this clinical trial is not currently open to enrollment. It was initially posted on April 1st 2014 and last updated on February 14th 2022. Nevertheless, there are ample opportunities for those seeking trials related to breast cancer or Cisplatin: 2351 studies are presently recruiting patients with the former condition while 1333 research sites seek enrollees for the latter."

Answered by AI

Are there any facilities in North America that are conducting the clinical trial?

"Patients can participate in this study at a variety of locations, including Indiana University- Simon Cancer Center (Indianapolis), Memorial Sloan Kettering Cancer Center-Rockville Centre (Rockville Centre, NY) and Memorial Sloan Kettering Cancer Center-Commack (Commack, TN). Additionally, there are 20 other sites participating."

Answered by AI

Recent research and studies

Annals of OncologyJournal

TBCRC 030: A Phase II Study of Preoperative Cisplatin Versus Paclitaxel in Triple-negative Breast Cancer: Evaluating the Homologous Recombination Deficiency (HRD) Biomarker

Mayer, E.L., V. Abramson, R. Jankowitz, C. Falkson, P.K. Marcom, T. Traina, L. Carey, et al.. 2020. “TBCRC 030: A Phase II Study of Preoperative Cisplatin Versus Paclitaxel in Triple-negative Breast Cancer: Evaluating the Homologous Recombination Deficiency (HRD) Biomarker”. Annals of Oncology. Elsevier BV. doi:10.1016/j.annonc.2020.08.2064.

clinicaltrials.govStudy

Cisplatin vs Paclitaxel for Triple Negative Breast Cancer

Erica Mayer, MD, MPH 2014. "Cisplatin vs Paclitaxel for Triple Negative Breast Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01982448.