Gefitinib With or Without Tamoxifen in Treating Patients With Tamoxifen-Resistant Metastatic Breast Cancer

NCT00080743 | Completed Phase 2 DMC

• 3 other identifiers: CDR0000355145DMS-0236ZENECA-IRUSIRES0162
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

Brief Summary

RATIONALE: Gefitinib may stop the growth of tumor cells by blocking the enzymes necessary for their growth. Hormone therapy using tamoxifen may fight breast cancer by blocking the use of estrogen by the tumor cells. Combining gefitinib with tamoxifen may be effective in killing tumor cells that have become resistant (stopped responding) to tamoxifen. PURPOSE: This randomized phase II trial is studying how well giving gefitinib together with tamoxifen works compared to gefitinib alone in treating patients with metastatic breast cancer that has stopped responding to tamoxifen.

Conditions

Breast Cancer

Keywords

recurrent breast cancer; stage IV breast cancer

Outcome Measures

Primary Outcomes (1)

• Clinical benefit rate (complete response, partial response, and stable disease) for 26 weeks

  26 weeks

Study Arms (2)

Tamoxifen

ACTIVE COMPARATOR

Tamoxifen 20 mg po once daily

Drug: gefitinib; Drug: tamoxifen citrate

Placebo

PLACEBO COMPARATOR

Placebo comparator one tablet po once daily

Drug: gefitinib; Drug: Placebo

Interventions

gefitinib DRUG

250 mg po once daily

Also known as: ZD1839, Iressa

Placebo; Tamoxifen

tamoxifen citrate DRUG

20 mg po once daily

Also known as: Nolvadex

Tamoxifen

Placebo DRUG

One pill po once daily

Also known as: Sugar pill

Placebo

Eligibility Criteria

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

DISEASE CHARACTERISTICS: * Histologically confirmed breast cancer * Metastatic disease * Initial clinical benefit from tamoxifen for metastatic disease, defined by 1 of the following: * Stable disease for 24 weeks or longer * Objective tumor response * Documentation of clinical progression on tamoxifen within the past 6 weeks * Hormone receptor status: * Estrogen or progesterone receptor positive on most recently analyzed biopsy PATIENT CHARACTERISTICS: Age * 18 and over Sex * Not specified Menopausal status * Not specified Performance status * ECOG 0-2 Life expectancy * At least 6 months Hematopoietic * Absolute neutrophil count ≥ 1,500/mm\^3 * Platelet count ≥ 100,000/mm\^3 Hepatic * AST ≤ 1.5 times upper limit of normal (ULN) * Bilirubin ≤ 1.5 times ULN Renal * Creatinine ≤ 1.5 times ULN OR * Creatinine clearance ≥ 50 mL/min Pulmonary * No clinically active interstitial lung disease * Patients with asymptomatic chronic stable radiographic changes are eligible Other * Not pregnant or nursing * Fertile patients must use effective contraception * No known hypersensitivity to gefitinib * No other malignancy within the past 5 years except basal cell carcinoma or carcinoma in situ of the cervix PRIOR CONCURRENT THERAPY: Biologic therapy * No concurrent trastuzumab (Herceptin®) Chemotherapy * No concurrent cytotoxic chemotherapy Endocrine therapy * See Disease Characteristics * At least 2 weeks since other prior tamoxifen * No concurrent hormone replacement therapy * No other concurrent antiestrogens, including raloxifene * No concurrent aromatase inhibitors * No concurrent megestrol * Concurrent systemic steroids for reasons other than skin toxicity allowed provided the steroids were initiated before study entry AND dose remains stable Radiotherapy * Concurrent palliative radiotherapy as short-term treatment for symptomatic bone metastases allowed provided other evaluable sites of disease are present AND treatment lasts no more than 14 days Surgery * Recovered from prior oncologic or other major surgery * No concurrent surgery during and for 7 days after study treatment * No concurrent ophthalmic surgery Other * Recovered from all prior therapy (except alopecia) * More than 30 days since prior investigational drugs * No other concurrent investigational agents * No concurrent administration of any of the following: * Phenytoin * Carbamazepine * Barbiturates * Rifampin * Phenobarbital * Hypericum perforatum (St. John's wort) * Systemic retinoids * CYP3A4 inhibitors (e.g., itraconazole) * Drugs that cause significant sustained elevation in gastric pH ≥ 5

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

Sponsors & Collaborators

• Dartmouth-Hitchcock Medical Center: lead
• National Cancer Institute (NCI): collaborator
• Norris Cotton Cancer Center: collaborator

Study Sites (1)

Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, 03756, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Gefitinib; Tamoxifen; Sugars

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Stilbenes; Benzylidene Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Carbohydrates

Study Officials

• Gary N. Schwartz, MD

  Norris Cotton Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: April 7, 2004
• First Posted: April 8, 2004
• Study Start: January 1, 2004
• Primary Completion: April 1, 2005
• Study Completion: November 1, 2005
• Last Updated: August 6, 2009

Record last verified: 2009-08

Locations

US (1)