HER2-positive Breast Cancer With Brain Metastasis (GCC 1345)

NCT01924351 | Withdrawn Phase 2 DMC

• 1 other identifier: HP-00056720
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

Primary Objective: To determine if treatment with SRS followed by a HER-2 directed therapy regimen results in a 6-month distant brain relapse rate of less than 30%. Secondary Objectives:

1. 1.Describe the natural history of neurocognitive function for women with brain metastases treated with SRS and HER-2 directed systemic therapy and establish a reference benchmark to generate hypothesis for future design of a phase III trial.
2. 2.Describe patterns of distant brain relapse after SRS for all patients and compare them between (a) patients with 1-3 vs. 4-10 brain metastasis and (b) between patients treated with each systemic therapy regimen
3. 3.Describe patterns of neurologic death
4. 4.Describe patterns of local brain relapse
5. 5.Describe patterns of re-irradiation with WBRT or SRS
6. 6.Describe adverse events

Conditions

Breast Cancer With Brain Metastasis

Keywords

Breast Cancer with Brain Metastasis; HER2-positive; HER-2 therapy

Outcome Measures

Primary Outcomes (1)

• Relaspe Rate (Primary)

  To determine if treatment with SRS followed by a HER-2 directed therapy regimen results in a 6-month distant brain relapse rate of less than 30%.

  12 months

Study Arms (1)

HER2-positive Breast Cancer with Brain Metastasis

OTHER

Stereotactic Radiosurgery plus HER-2 directed therapy in HER2-positive Breast Cancer with Brain Metastasis

Radiation: Stereotactic Radiosurgery plus HER-2 directed therapy in HER2-positive Breast Cancer with Brain Metastasis

Interventions

Stereotactic Radiosurgery plus HER-2 directed therapy in HER2-positive Breast Cancer with Brain Metastasis RADIATION

HER2-positive Breast Cancer with Brain Metastasis

Eligibility Criteria

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

You may qualify if:

• Histologically proven diagnosis HER2-positive breast cancer. Her2-positive is defined as follows:
• \* Validated IHC assay score of 3+ (defined as uniform, intense staining of \>30% of invasive tumor cells)
• OR- Average HER2 gene copy number of \>6
• OR- Gene amplified (HER2:D17Z1 ratio \>2.20).
• Patients with 1-10 newly diagnosed brain metastases
• The contrast-enhancing intraparenchymal brain tumor must be well circumscribed and must have a maximum diameter of ≤ 4.0 cm in any direction on the enhanced scan. If multiple lesions are present and one lesion is at the maximum diameter, the other(s) must not exceed 3.0 cm in maximum diameter.
• History and physical with neurological examination, steroid documentation, height, and weight within 14 days of registration.
• A diagnostic contrast-enhanced MRI of the brain must be performed within 28 days prior to registration.
• Eligibility for treatment with SRS confirmed by a radiation oncologist.
• Performance Status 0-2
• Age ≥ 18.
• CBC with differential obtained within 14 days prior to registration, with adequate bone marrow function defined as follows:
• Absolute neutrophil count (ANC) ≥ 1,100 cells/mm3.
• Platelets ≥ 75,000 cells/mm3.
• Hemoglobin ≥ 9.0 g/dl (Note: The use of transfusion or other intervention to achieve Hgb ≥9.0 g/dl is acceptable).

You may not qualify if:

• Prior invasive malignancy (except for non-melanomatous skin cancer) unless disease free for ≥ 3 years. For example, carcinoma in situ of the oral cavity and cervix are all permissible.
• Leptomeningeal metastases
• Previous treatment with all of the following: lapatinib, trastuzumab, pertuzumab, and trastuzumab emtansine. (Patients are eligible if treated with 3 or less of these agents.)
• Prior cranial radiotherapy.
• Prior resection of cerebral metastases
• Allergy to gadolinium
• Severe, active co-morbidity, defined as follows:
• Unstable angina and/or congestive heart failure within the last 6 months.
• Transmural myocardial infarction within the last 6 months.
• New York Heart Association grade II or greater congestive heart failure requiring hospitalization within 12 months prior to registration.
• History of stroke, cerebral vascular accident (CVA) or transient ischemic attack within 6 months.
• Serious and inadequately controlled cardiac arrhythmia.
• Significant vascular disease (e.g., aortic aneurysm, history of aortic dissection) or clinically significant peripheral vascular disease.
• Evidence of bleeding diathesis or coagulopathy.
• Serious or non-healing wound, ulcer, or bone fracture or history of abdominal fistula, gastrointestinal perforation or intra-abdominal abscess, major surgical procedure or significant traumatic injury within 28 days prior to registration, with the exception of the craniotomy for tumor resection or follow-on craniotomies to manage complications of brain tumor management such as hemorrhage or infection.

Sponsors & Collaborators

• University of Maryland, Baltimore: lead

Study Sites (1)

Ummc Msgcc

Baltimore, Maryland, 21201, United States

Location

MeSH Terms

Interventions

Radiosurgery

Intervention Hierarchy (Ancestors)

Radiotherapy; Therapeutics; Stereotaxic Techniques; Neurosurgical Procedures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Elizabeth Nichols, M.D.

  Univerysity of Maryland Baltimore

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 13, 2013
• First Posted: August 16, 2013
• Study Start: February 1, 2015
• Primary Completion: June 1, 2016
• Study Completion: June 1, 2016
• Last Updated: March 18, 2020

Record last verified: 2020-03

Locations

US (1)