Cisplatin and Radiation Therapy in Treating Patients with Stage II-III Triple Negative Breast Cancer

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Basic Trial Information

PhaseTypeStatusAgeTrial IDs
Phase ITreatmentActive18 and over12-283
NCI-2012-02219, NCT01674842

Trial Description

Summary

This phase I trial studies the side effects and the best dose of cisplatin when given together with radiation therapy in treating patients with stage II-III breast cancer that does not have estrogen receptors, progesterone receptors, or large amounts of human epidermal growth factor receptor 2 (HER2)/neu protein. Drugs used in chemotherapy, such as cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Giving cisplatin together with radiation therapy may kill more tumor cells.

Further Study Information

PRIMARY OBJECTIVES:

I. 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.

SECONDARY OBJECTIVES:

I. To assess local recurrence at 5-years in participants receiving cisplatin concurrently with radiation (radiation therapy), as compared with historic controls receiving radiation without concurrent chemotherapy.

II. To assess long-term toxicity in participants receiving cisplatin concurrently with radiation.

OUTLINE: This is a dose-escalation study of cisplatin.

Patients receive cisplatin intravenously (IV) once weekly and undergo radiation therapy daily 5 days a week. Treatment continues for 6 weeks in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up at 3 months and then every 6 months for 5 years.

Eligibility Criteria

Inclusion Criteria:

The primary tumor must be triple negative breast cancer (i.e., the invasive tumor must be estrogen receptor [ER]-negative and progesterone receptor [PR]-negative, or stain < 10% by immunohistochemistry [IHC]; the invasive tumor must be HER2-negative, defined as 0 or 1+ by IHC or fluorescent in situ hybridization [FISH] < 2.0)

Breast-conserving surgery or mastectomy with surgical excision of all gross disease with negative surgical margins

Participants undergoing definitive surgery at diagnosis must have pathologic stage II or III disease

Participants undergoing preoperative systemic therapy must have clinical stage II or III disease at presentation (clinical stage I disease is excluded)

Participants undergoing preoperative systemic therapy must have residual invasive disease in the breast or axillary lymph nodes at the time of definitive surgery

Any prior systemic therapy is permitted (except cisplatin or carboplatin)

Minimum 3-week interval from last chemotherapy administration and last breast surgery to radiation

Maximum 8-week interval from last chemotherapy administration or last breast surgery (whichever is more recent) to radiation

Absolute neutrophil count greater than 1500/mm^3

Platelet count greater than 100,000/mm^3

Serum glutamic oxaloacetic transaminase (SGOT) and serum glutamate pyruvate transaminase (SGPT) =< 2.5 times upper limit of normal

Bilirubin =< 1.5 mg/dl

Glomerular filtration rate (GFR) >= 60 ml/min

Negative urine pregnancy test within 2 weeks of registration for women of child-bearing potential; women of child-bearing potential must have a documented negative pregnancy test and agree to use adequate contraception throughout the study period

Ability and willingness to sign written informed consent

Patients with tumors of two different subtypes will be eligible provided that the triple negative tumor otherwise meets eligibility requirements, and the non-triple negative tumor is < 1.0 cm in size

Patients with inflammatory breast cancer are eligible for the escalation phase of the mastectomy cohort

Exclusion Criteria:

Prior radiation therapy to the breast or ipsilateral regional nodes not allowed (a history of radiation therapy to other sites is permissible)

Ongoing therapy with other investigational agents

Hormonal therapy (tamoxifen, an aromatase inhibitor, or Lupron) is not permitted during radiation or during the subsequent 4 weeks (the entire dose-limiting toxicity [DLT] window)

Unresolved toxicity from other agents; participants with unresolved or unstable Common Toxicity Criteria Adverse Event version 4 (CTCAE v4) grade 2 or greater toxicity from prior administration of another anti-cancer treatment are not eligible

Significant comorbidity: ineligible participants include those with clinically significant and uncontrolled major cardiac, respiratory, renal hepatic, gastrointestinal, hematologic, or neurologic/psychiatric disease or disorder, including, but not limited to: active or uncontrolled infection, symptomatic congestive heart failure, unstable angina, cardiac arrhythmias, or any other illness or condition that could exacerbate potential toxicities, confound safety assessment or limit compliance with study requirements

Pregnant women are excluded from this study

Pathologic complete response following preoperative chemotherapy

Participants with biopsy proven metastatic disease (M1)

Peripheral neuropathy greater than grade 1

Hearing loss greater than grade 1

Inflammatory breast cancer patients are ineligible, except in the escalation phase of the mastectomy cohort

Trial Contact Information

Trial Lead Organizations / Sponsors / Collaborators

Dana-Farber Harvard Cancer Center

  • National Cancer Institute
Jennifer Ruth Bellon, Principal Investigator

Trial Sites

U.S.A.

Massachusetts
Boston

Brigham and Women's Hospital

Jennifer Ruth Bellon
Ph: 617-632-3591
Email: jbellon@lroc.harvard.edu

Jennifer Ruth Bellon
Principal Investigator

Dana-Farber Cancer Institute

Jennifer Ruth Bellon
Ph: 617-632-3591
Email: jbellon@lroc.harvard.edu

Jennifer Ruth Bellon
Principal Investigator

Charlestown

Massachusetts General Hospital

Steven Jay Isakoff
Ph: 781-624-4700
Email: sisakoff@partners.org

Steven Jay Isakoff
Principal Investigator

South Weymouth

Dana-Farber/Brigham and Women's Cancer Center at South Shore

Tatiana I. Lingos
Ph: 508-488-3835
Email: tlingos@partners.org

Tatiana I. Lingos
Principal Investigator

Link to the current ClinicalTrials.gov record.
NLM Identifier NCT01674842

Note: Information about participating sites on pharmaceutical industry trials may be incomplete. Please visit the ClinicalTrials.gov record via the link above for more information about participating sites.