CompletedPhase 1/2

Monoclonal Antibody Compared With Zoledronate in Treating Women With Breast Cancer and Bone Metastases

United StatesStarted 2002-11

Plain-language summary

RATIONALE: Monoclonal antibodies can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Zoledronate may prevent bone loss and stop the growth of tumor cells in bone. It is not yet known whether monoclonal antibody is more effective than zoledronate in treating women who have breast cancer and bone metastases. PURPOSE: Randomized phase I/II trial to compare the effectiveness of monoclonal antibody with that of zoledronate in treating women who have breast cancer and bone metastases.

Who can participate

Age range

18 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

DISEASE CHARACTERISTICS: * Histologically or cytologically confirmed breast cancer * Radiographical evidence of at least 1 bone metastasis * No prior radiotherapy or surgery to bone metastasis * No radiotherapy or surgery anticipated for bone metastasis within the next 24 weeks * Bone pain severity score of at least 1 on 5 of 7 days as determined by question 3 of the Brief Pain Inventory (BPI) * No bone metastases to a weight-bearing bone at imminent risk for pathologic fracture or surgical intervention * No vertebral metastases that place the patient at imminent risk of spinal cord compression * Hormone receptor status: * Not specified PATIENT CHARACTERISTICS: Age * 18 and over Sex * Female Menopausal status * Pre- or post-menopausal Performance status * ECOG 0-2 Life expectancy * At least 6 months Hematopoietic * WBC at least 2,000/mm\^3 * Lymphocyte count at least 500/mm\^3 * Granulocyte count at least 1,000/mm\^3 * Platelet count at least 50,000/mm\^3 Hepatic * ALT or AST no greater than 2.5 times upper limit of normal (ULN) * Bilirubin no greater than 1.5 times ULN Renal * Calcium no greater than 10.1 mg/dL * No oliguria, defined as less than 30 mL urine per 2-hour collection * No acute renal failure * Creatinine no greater than 2.5 mg/dL Other * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective barrier contraception * No sepsis * No known or anticipated contraindication to study drugs PRIOR CONCURRENT TH…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

Trial details

NCT IDNCT00060138

SponsorChugai Pharmaceutical

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2004-09

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