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Radiation Therapy With or Without Temozolomide in Treating Women With Brain Metastases and Breast Cancer

Primary Purpose

Breast Cancer, Metastatic Cancer

Status

Unknown status

Phase

Phase 2

Locations

France

Study Type

Interventional

Intervention

temozolomide

radiation therapy

About this trial

This is an interventional treatment trial for Breast Cancer focused on measuring tumors metastatic to brain, stage IV breast cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

DISEASE CHARACTERISTICS:

Diagnosis of breast cancer
- Unresectable disease or patient refused surgery
Must have brain metastases

PATIENT CHARACTERISTICS:

WHO performance status 0-2
ANC ≥ 1,500/mm³
Platelet count ≥ 100,000/mm³
Liver transaminases ≤ 1.5 times upper limit of normal (ULN)
Creatinine < 1.5 times ULN
Not pregnant or nursing
Fertile patients must use effective contraception
No carcinomatous meningitis
No history of cancer except for basal cell carcinoma of the skin or carcinoma in situ of the cervix
No other serious concurrent disease that is, in the opinion of the investigator, likely to interfere with study evaluation and treatment
No contraindications to treatment with temozolomide
No psychological, familial, social, or geographic situations that preclude clinical follow up
No patient deprived of liberty or under guardianship

PRIOR CONCURRENT THERAPY:

No prior brain radiotherapy
At least 10 days since prior chemotherapy

Sites / Locations

Institut Curie HopitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Arm I

Arm II

Arm Description

Patients undergo isocentric radiotherapy to the brain 5 times a week for 2 weeks.

Patients undergo radiotherapy as in arm I and receive oral temozolomide once daily for 2 weeks.

Outcomes

Primary Outcome Measures

Response at 6 weeks as assessed by MRI and/or scan

Secondary Outcome Measures

Full Information

NCT ID

NCT00875355

First Posted

April 2, 2009

Last Updated

August 25, 2009

Sponsor

Institut Curie

1. Study Identification

Unique Protocol Identification Number

NCT00875355

Brief Title

Radiation Therapy With or Without Temozolomide in Treating Women With Brain Metastases and Breast Cancer

Official Title

Phase II Randomized Multicenter Study Comparing Brain Radiation in Combination With Temozolomide or Radiation Alone in Patients With Brain Metastases From Breast Cancer

Study Type

Interventional

2. Study Status

Record Verification Date

July 2009

Overall Recruitment Status

Unknown status

Study Start Date

November 2007 (undefined)

Primary Completion Date

November 2009 (Anticipated)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

Institut Curie

4. Oversight

5. Study Description

Brief Summary

RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. It is not yet known whether radiation therapy is more effective when given alone or together with temozolomide in treating brain metastases secondary to breast cancer. PURPOSE: This randomized phase II trial is studying how well radiation therapy given together with temozolomide works compared with radiation therapy given alone in treating women with brain metastases and breast cancer.

Detailed Description

OBJECTIVES: Primary Compare the objective response rate at 6 weeks in women with brain metastases secondary to breast cancer treated with radiotherapy with vs without temozolomide. Secondary Evaluate the tolerability. Compare the duration of response. Compare local progression-free survival. Compare overall survival. OUTLINE: This is a multicenter study. Patients are randomized to 1 of 2 treatment arms. Arm I: Patients undergo isocentric radiotherapy to the brain 5 times a week for 2 weeks. Arm II: Patients undergo radiotherapy as in arm I and receive oral temozolomide once daily for 2 weeks. After completion of study treatment, patients are followed at 3 and 6 months and then every 6 months for 2 years.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Breast Cancer, Metastatic Cancer

Keywords

tumors metastatic to brain, stage IV breast cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Allocation

Randomized

Enrollment

100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Arm I

Arm Type

Experimental

Arm Description

Patients undergo isocentric radiotherapy to the brain 5 times a week for 2 weeks.

Arm Title

Arm II

Arm Type

Experimental

Arm Description

Patients undergo radiotherapy as in arm I and receive oral temozolomide once daily for 2 weeks.

Intervention Type

Drug

Intervention Name(s)

temozolomide

Intervention Description

Given orally

Intervention Type

Radiation

Intervention Name(s)

radiation therapy

Intervention Description

Patients undergo radiotherapy

Primary Outcome Measure Information:

Title

Response at 6 weeks as assessed by MRI and/or scan

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

DISEASE CHARACTERISTICS: Diagnosis of breast cancer Unresectable disease or patient refused surgery Must have brain metastases PATIENT CHARACTERISTICS: WHO performance status 0-2 ANC ≥ 1,500/mm³ Platelet count ≥ 100,000/mm³ Liver transaminases ≤ 1.5 times upper limit of normal (ULN) Creatinine < 1.5 times ULN Not pregnant or nursing Fertile patients must use effective contraception No carcinomatous meningitis No history of cancer except for basal cell carcinoma of the skin or carcinoma in situ of the cervix No other serious concurrent disease that is, in the opinion of the investigator, likely to interfere with study evaluation and treatment No contraindications to treatment with temozolomide No psychological, familial, social, or geographic situations that preclude clinical follow up No patient deprived of liberty or under guardianship PRIOR CONCURRENT THERAPY: No prior brain radiotherapy At least 10 days since prior chemotherapy

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Youlia Kirova

Organizational Affiliation

Institut Curie

Official's Role

Principal Investigator

Facility Information:

Facility Name

Institut Curie Hopital

City

Paris

ZIP/Postal Code

75248

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Youlia Kirova

Phone

33-44-32-4000

12. IPD Sharing Statement

Citations:

PubMed Identifier

25355723

Citation

Cao KI, Lebas N, Gerber S, Levy C, Le Scodan R, Bourgier C, Pierga JY, Gobillion A, Savignoni A, Kirova YM. Phase II randomized study of whole-brain radiation therapy with or without concurrent temozolomide for brain metastases from breast cancer. Ann Oncol. 2015 Jan;26(1):89-94. doi: 10.1093/annonc/mdu488. Epub 2014 Oct 29.

Results Reference

derived

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Radiation Therapy With or Without Temozolomide in Treating Women With Brain Metastases and Breast Cancer

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