NCT01674842

Brief Summary

This is a Phase I dose escalation study of cisplatin and concurrent radiation in patients with ER negative, PR negative and HER2 negative breast cancer who have undergone breast-conserving surgery or mastectomy. Primary objective: To assess the safety, tolerability, and maximum tolerated dose (MTD) of cisplatin when given concurrently with radiation therapy for participants with Stage II or III breast cancer who have undergone breast conserving surgery or mastectomy

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
55

participants targeted

Target at P50-P75 for phase_1 breast-cancer

Timeline
Completed

Started Oct 2012

Longer than P75 for phase_1 breast-cancer

Geographic Reach
1 country

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 23, 2012

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 29, 2012

Completed
1 month until next milestone

Study Start

First participant enrolled

October 1, 2012

Completed
5.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2018

Completed
2.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 8, 2021

Completed
Last Updated

August 25, 2021

Status Verified

August 1, 2021

Enrollment Period

5.8 years

First QC Date

August 23, 2012

Last Update Submit

August 23, 2021

Conditions

Breast Cancer

Keywords

Triple negativeStage IIStage III

Outcome Measures

Primary Outcomes (1)

  • Safety of Cisplatin w/ Radiation

    To determine the maximum tolerated dose of cisplatin when given concurrently with radiation therapy for participants with Stage II or III breast cancer who have undergone breast conserving surgery or mastectomy.

    2 years

Secondary Outcomes (2)

  • Local recurrence at 5 years

    5 years

  • Long term toxicity

    2 years

Study Arms (1)

Cisplatin + Radiation Therapy

EXPERIMENTAL

Cisplatin concurrently with radiation therapy

Radiation: Radiation TherapyDrug: Cisplatin

Interventions

Radiation TherapyRADIATION

Once daily, Monday - Friday for six weeks

Cisplatin + Radiation Therapy
CisplatinDRUG

Intravenously, once weekly for six weeks

Also known as: CDDP
Cisplatin + Radiation Therapy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Primary tumor is triple negative breast cancer
  • Breast-conserving surgery or mastectomy with surgical excision of all gross disease with negative surgical margins
  • Pathologic or clinical stage II or III disease
  • At least 3 week interval from last chemotherapy administration/breast surgery to radiation (no more than 8 weeks)

You may not qualify if:

  • Pregnant or breastfeeding
  • Prior radiation to breast or ipsilateral regional nodes
  • Ongoing therapy with other investigational agents
  • Hormonal therapy
  • Significant co-morbidity
  • Pathologic complete response following preoperative chemotherapy
  • Biopsy proven metastatic disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Dana-Farber Cancer Institute

Boston, Massachusetts, 02115, United States

Location

Dana-Farber at Milford

Milford, Massachusetts, 01757, United States

Location

Dana Farber at South Shore Hospital

Weymouth, Massachusetts, 02190, United States

Location

Related Publications (1)

  • Bellon JR, Chen YH, Rees R, Taghian AG, Wong JS, Punglia RS, Shiloh RY, Warren LEG, Krishnan MS, Phillips J, Pretz J, Jimenez R, Macausland S, Pashtan I, Andrews C, Isakoff SJ, Winer EP, Tolaney SM. A Phase 1 Dose-Escalation Trial of Radiation Therapy and Concurrent Cisplatin for Stage II and III Triple-Negative Breast Cancer. Int J Radiat Oncol Biol Phys. 2021 Sep 1;111(1):45-52. doi: 10.1016/j.ijrobp.2021.03.002. Epub 2021 Mar 10.

    PMID: 33713742DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Interventions

RadiotherapyCisplatin

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

TherapeuticsChlorine CompoundsInorganic ChemicalsNitrogen CompoundsPlatinum Compounds

Study Officials

  • Jennifer R Bellon, MD

    Dana-Farber Cancer Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Invstigator

Study Record Dates

First Submitted

August 23, 2012

First Posted

August 29, 2012

Study Start

October 1, 2012

Primary Completion

August 1, 2018

Study Completion

June 8, 2021

Last Updated

August 25, 2021

Record last verified: 2021-08

Locations

US(5)