Temozolomide as a Prophylaxis Against Brain Recurrence in Participants With Metastatic Breast Cancer (P05225 AM2)

NCT00638963 | Terminated Phase 2 Results

• 2 other identifiers: P052252007-005491-14
• Study Type: interventional
• Target: 6
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to determine whether temozolomide can be used as a prophylaxis against brain recurrence in participants with metastatic breast cancer.

Conditions

Breast Neoplasm; Brain Neoplasm; Second Neoplasm

Outcome Measures

Primary Outcomes (1)

• Percent of Participants With Recurrence of Brain Metastases

  The analysis could not be performed due to low enrollment.

  1 Year

Secondary Outcomes (9)

• Number of Days With Progression-free Survival (PFS)

  24, 38, and 52 weeks

• Number of Days With Disease-free Survival (DFS)

  24, 38, and 52 weeks

• Number of Days With Distant Disease-free Survival (DDFS)

  24, 38, and 52 weeks

• Number of Days With Brain Recurrence-free Survival (BRFS)

  24,38, and 52 weeks

• Number of Days on Temozolomide Treatment

  Baseline to 24 Weeks

Study Arms (2)

Temozolomide

EXPERIMENTAL

Drug: temozolomide

Observational

NO INTERVENTION

Interventions

temozolomide DRUG

Capsules to equal 75 mg/m\^2, orally, daily for 6 weeks, in 3 eight-week cycles

Temozolomide

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of metastatic breast cancer.
• Participants must have completed first line of metastatic chemotherapy and have achieved complete or partial response or disease stability for at least 6 months from the first confirmation of disease stabilization.
• No clinical sign of brain progression.
• At least one of the following 3 conditions: HER2 +++, Young age (\< 50 years), and/or estrogen receptor (ER)-/progesterone receptor (PgR)-
• Eastern Cooperative Oncology Group (ECOG) performance status ≤2.
• Life expectancy ≥3 months.
• Neutrophils ≥1.5 x 10\^9/L, platelets ≥100 x 10\^9/L, hemoglobin ≥9 g/dL, lymphocytes ≥1 x 10\^9/L.
• Bilirubin level either normal or \<1.5 x ULN (upper limit of normal).
• AST (aspartate aminotransferase) and ALT (alanine aminotransferase) ≤2.5 x ULN (≤5 x ULN if liver metastases are present).
• Serum creatine \<1.5 x ULN.
• Effective contraception if the risk of conception exists.

You may not qualify if:

• Concurrent chronic systemic immune therapy not indicated in the study protocol.
• Any investigational agent(s) within 4 weeks prior to entry.
• Participants that have completed 2nd, 3rd, or 4th line metastatic chemotherapy or participant in active chemotherapy treatment.
• Clinically relevant coronary artery disease or a history of a myocardial infarction within the last 12 months.
• Acute or sub acute intestinal occlusion or history of inflammatory bowel disease.
• Known Grade 3 or Grade 4 allergic reaction to any of the components of the treatment.
• Known drug abuse/alcohol abuse.
• Legal incapacity or limited legal capacity.
• Medical or psychological condition which in the opinion of the investigator would not permit the participant to complete the study or sign meaningful informed consent.
• Women who are pregnant or breastfeeding.
• Any concurrent malignancy other than non-melanoma skin cancer, or carcinoma in situ of the cervix (participants with a previous malignancy but without evidence of disease for ≥5 years will be allowed to enter the trial).

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

MeSH Terms

Conditions

Breast Neoplasms; Brain Neoplasms; Neoplasms, Second Primary

Interventions

Temozolomide

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Central Nervous System Neoplasms; Nervous System Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Dacarbazine; Triazenes; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Limitations and Caveats

The primary outcome measure and the survival analyses could not be analyzed due to the low enrollment.

Results Point of Contact

• Title: Senior Vice President, Global Clinical Development
• Organization: Merck Sharp & Dohme Corp.

ClinicalTrialsDisclosure@merck.com

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 10, 2008
• First Posted: March 19, 2008
• Study Start: October 2, 2008
• Primary Completion: June 30, 2010
• Study Completion: June 30, 2010
• Last Updated: June 14, 2017
• Results First Posted: July 22, 2011

Record last verified: 2017-05

Data Sharing

• IPD Sharing: Will share