Saracatinib in Treating Patients With Metastatic or Locally Advanced Breast Cancer That Cannot Be Removed By Surgery

NCT00559507 | Completed Phase 2 Results

• 5 other identifiers: NCI-2009-00191MSKCC-07112N01CM62204N01CM62206CDR0000574281
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

This phase II trial is studying saracatinib to see how well it works in treating patients with metastatic or locally advanced breast cancer that cannot be removed by surgery. Saracatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth

Conditions

Estrogen Receptor-negative Breast Cancer; Male Breast Cancer; Progesterone Receptor-negative Breast Cancer; Recurrent Breast Cancer; Stage IIIB Breast Cancer; Stage IIIC Breast Cancer; Stage IV Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Disease Control Rate (DCR)

  DCR defined as complete response (CR), partial response (PR), stable disease (SD) \> 24 weeks. Simon's two-stage optimal design was used to estimate the DCR of AZD0530 after 24 weeks of therapy since this design allowed for early termination of the study. Response and progression was evaluated in this study using the Response Evaluation Criteria in Solid Tumors (RECIST) Target lesions: Complete Response (CR): Disappearance of all target lesions Partial Response (PR): At least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD Progressive Disease (PD): At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started

  After 24 weeks of study therapy

Secondary Outcomes (2)

• Overall Response Rate (CR and PR)

  From start of treatment to 24 weeks after completion of study treatment

• Median Time to Treatment Failure

  From the start of treatment up to 4 weeks after completion of study treatment

Study Arms (1)

Treatment (enzyme inhibitor therapy)

EXPERIMENTAL

Patients receive saracatinib PO on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.

Drug: saracatinib; Other: laboratory biomarker analysis

Interventions

saracatinib DRUG

Also known as: AZD0530

Treatment (enzyme inhibitor therapy)

laboratory biomarker analysis OTHER

Correlative studies

Treatment (enzyme inhibitor therapy)

Eligibility Criteria

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

You may qualify if:

• Histologically or cytologically confirmed carcinoma of the breast
• Unresectable disease
• Locally advanced or metastatic (American Joint Committee on Cancer \[AJCC\] stage IV) disease
• Estrogen receptor-negative and progesterone receptor-negative breast cancer defined as \< 10% expression by immunohistochemistry (IHC)
• Measurable disease, defined (per Response Evaluation Criteria in Solid Tumors \[RECIST\]) as ≥ 1 unidimensionally measurable lesion ≥ 20mm by conventional techniques or ≥ 10 mm by spiral computed tomography (CT) scan
• Measurable target lesions must not be in a previously irradiated field
• Patients with locally advanced, unresectable disease must have progression of disease following no more than one first-line chemotherapy regimen
• Patients with evidence of recurrent disease during or within 6 months after adjuvant chemotherapy will be considered to have failed one line of chemotherapy for metastatic disease
• Human epidermal growth factor receptor 2 (HER2)-positive patients, defined as immunohistochemistry (IHC) 3+ or fluorescence in situ hybridization (FISH) amplification \> 2.1, must have received trastuzumab (Herceptin®) in either the adjuvant or metastatic setting and have had recurrence or progression of disease, respectively
• No known brain metastases
• Male and female patients eligible
• Menopausal status not specified
• Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤ 2 (Karnofsky PS 60-100%)
• Life expectancy \> 3 months
• Absolute neutrophil count ≥ 1,500/mcL

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (1)

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

MeSH Terms

Conditions

Breast Neoplasms, Male; Breast Neoplasms

Interventions

saracatinib

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Results Point of Contact

• Title: Clifford Hudis, MD
• Organization: Memorial Sloan-Kettering Cancer Center

hudisc@mskcc.org

646-888-4551

Study Officials

• Clifford Hudis

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 15, 2007
• First Posted: November 16, 2007
• Study Start: October 1, 2007
• Primary Completion: February 1, 2011
• Study Completion: February 1, 2011
• Last Updated: April 30, 2014
• Results First Posted: January 20, 2014

Record last verified: 2013-12

Locations

US (1)