Everolimus in Treating Patients WIth Recurrent or Metastatic Breast Cancer

NCT00255788 | Completed Phase 2 DMC

• 4 other identifiers: I163CAN-NCIC-IND163NOVARTIS-CAN-NCIC-IND163CDR0000450849
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 5

Brief Summary

RATIONALE: Everolimus may stop the growth of tumor cells by blocking blood flow to the tumor. PURPOSE: This randomized phase II trial is studying two different schedules of everolimus to see how well they work in treating patients with recurrent or metastatic breast cancer.

Conditions

Breast Cancer

Keywords

recurrent breast cancer; stage IV breast cancer; male breast cancer

Outcome Measures

Primary Outcomes (2)

• Response rate by clinical evaluation every 4 weeks and radiologic reevaluation every 8 weeks

• Early progression rate by clinical evaluation every 4 weeks and radiologic reevaluation every 8 weeks

Secondary Outcomes (5)

• Adverse event rates

• Time to progression by clinical evaluation every 4 weeks and radiologic reevaluation every 8 weeks

• Response duration by evaluation 4 weeks after response and then every 8 weeks

• Correlative assessment of response with molecular markers of mTor activity on archival tissue

• Optional correlative assessment of response with molecular markers of mTor activity on fresh tissue

Study Arms (2)

Arm A

ACTIVE COMPARATOR

Everolimus - 28 days q 4 wk

Drug: everolimus

Arm B

ACTIVE COMPARATOR

Everolimus - days 1, 8, 15 and 22 q 4wks

Drug: everolimus

Interventions

everolimus DRUG

Arm A; Arm B

Eligibility Criteria

• Age: 16 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: * Histologically confirmed breast cancer * Metastatic or recurrent disease * Considered incurable * Measurable disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques or ≥ 10 mm by spiral CT scan * Two primary breast cancers allowed * Paraffin-embedded primary or metastatic tumor sample available * No known brain metastases * Hormone receptor status: * Not specified PATIENT CHARACTERISTICS: Sex * Male or female Menopausal status * Not specified Performance status * ECOG 0-2 Life expectancy * Not specified Hematopoietic * Absolute granulocyte count ≥ 1,500/mm\^3 * Platelet count ≥ 100,000/mm\^3 Hepatic * Bilirubin ≤ 1.5 times upper limit of normal (ULN) * AST and ALT ≤ 2.5 times ULN Renal * Creatinine ≤ 1.5 times ULN Other * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No active uncontrolled infection * No upper gastrointestinal condition or other condition that would preclude ability to take oral medication * No other serious medical condition that would preclude study participation * No psychiatric illness or neurologic disorder that would preclude study compliance * No other malignancy within the past 5 years except curatively treated nonmelanoma skin cancer or carcinoma in situ of the cervix or bladder PRIOR CONCURRENT THERAPY: Chemotherapy * At least 4 weeks since prior chemotherapy * Prior adjuvant chemotherapy allowed * No more than 1 prior chemotherapy regimen for metastatic or recurrent disease Endocrine therapy * At least 5 days since prior hormonal therapy Radiotherapy * At least 4 weeks since prior radiotherapy except for low-dose, limited-fraction, palliative, nonmyelosuppressive radiotherapy, defined as radiotherapy to \< 20% of functioning bone marrow * If prior radiotherapy was to sole site of disease, must have subsequent documented disease progression at that site Surgery * At least 3 weeks since prior major surgery Other * Concurrent prophylactic bisphosphonates allowed, if started prior to study entry * No concurrent potent inhibitors of cytochrome 3A4, such as erythromycin, diltiazem, or ketoconazole and similar antifungals * No other concurrent anticancer therapy * No other concurrent investigational agents * No concurrent grapefruit juice

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• NCIC Clinical Trials Group: lead

Study Sites (5)

British Columbia Cancer Agency - Centre for the Southern Interior

Kelowna, British Columbia, V1Y 5L3, Canada

Location

Fraser Valley Cancer Centre at British Columbia Cancer Agency

Surrey, British Columbia, V3V 1Z2, Canada

Location

British Columbia Cancer Agency - Vancouver Cancer Centre

Vancouver, British Columbia, V5Z 4E6, Canada

Location

Margaret and Charles Juravinski Cancer Centre

Hamilton, Ontario, L8V 5C2, Canada

Location

Toronto Sunnybrook Regional Cancer Centre at Sunnybrook and Women's College Health Sciences Centre

Toronto, Ontario, M4N 3M5, Canada

Location

Related Publications (1)

• Ellard SL, Clemons M, Gelmon KA, Norris B, Kennecke H, Chia S, Pritchard K, Eisen A, Vandenberg T, Taylor M, Sauerbrei E, Mishaeli M, Huntsman D, Walsh W, Olivo M, McIntosh L, Seymour L. Randomized phase II study comparing two schedules of everolimus in patients with recurrent/metastatic breast cancer: NCIC Clinical Trials Group IND.163. J Clin Oncol. 2009 Sep 20;27(27):4536-41. doi: 10.1200/JCO.2008.21.3033. Epub 2009 Aug 17.

  PMID: 19687332 RESULT

MeSH Terms

Conditions

Breast Neoplasms; Breast Neoplasms, Male

Interventions

Everolimus

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Sirolimus; Macrolides; Lactones; Organic Chemicals

Study Officials

• Susan Ellard, MD

  British Columbia Cancer Agency - Centre for the Southern Interior

  STUDY CHAIR

• Karen A. Gelmon, MD

  British Columbia Cancer Agency

  STUDY CHAIR

Study Design

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

Study Record Dates

• First Submitted: November 18, 2005
• First Posted: November 21, 2005
• Study Start: May 10, 2005
• Primary Completion: July 22, 2008
• Study Completion: January 18, 2011
• Last Updated: August 4, 2023

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (5)