Trial Outcomes & Findings for Zoledronate in Treating Bone Marrow Micrometastases in Women With Stage I, Stage II, or Stage III Breast Cancer (NCT NCT00295867)

NCT ID: NCT00295867

Last Updated: 2020-05-12

Results Overview

Median change in disseminated tumor cells (DTCs)/mL from baseline after 24 months

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

45 participants

Primary outcome timeframe

up to 2 years

Results posted on

2020-05-12

Participant Flow

Patients were enrolled between October 2004 and October 2007. Patients were recruited in a medical clinic at the University of California, San Francisco Helen Diller Family Comprehensive Cancer Center.

Participant milestones

Participant milestones
Measure	Zoledronic Acid Patients who had greater than 4 disseminated tumor cells (DTCs)/mL present following neoadjuvant or adjuvant chemotherapy for early stage breast cancer were treated with 4mg zoledronic acid each month for 24 months.
Overall Study STARTED	45
Overall Study COMPLETED	34
Overall Study NOT COMPLETED	11

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Zoledronate in Treating Bone Marrow Micrometastases in Women With Stage I, Stage II, or Stage III Breast Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Zoledronic Acid n=45 Participants Patients who had greater than 4 disseminated tumor cells (DTCs)/mL present following neoadjuvant or adjuvant chemotherapy for early stage breast cancer were treated with 4mg zoledronic acid each month for 24 months.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	45 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	46 years n=5 Participants
Sex: Female, Male Female	45 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Region of Enrollment United States	45 participants n=5 Participants

PRIMARY outcome

Timeframe: up to 2 years

Population: Only 34 patients had bone marrow aspiration (BMA) at 24 mos required for this analysis

Median change in disseminated tumor cells (DTCs)/mL from baseline after 24 months

Outcome measures

Outcome measures
Measure	Zoledronic Acid n=34 Participants Patients who had greater than 4 disseminated tumor cells (DTCs)/mL present following neoadjuvant or adjuvant chemotherapy for early stage breast cancer were treated with 4mg zoledronic acid each month for 24 months.
Response of Bone Marrow Micrometastases	-4.5 DTCs/mL Interval -5.9 to 43.1

SECONDARY outcome

Timeframe: up to 2 years

Population: N-telopeptide levels in urine data not collected

N-telopeptide levels in urine will be recorded to evaluate the effect of zoledronic acid on bone mineralization (nmol bone collagen equivalents/mmol creatinine) at baseline and after 24 months on study treatment

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: up to 5 years post initiation of treatment

Distant breast cancer recurrence is when the cancer has spread to another organ within the body.

Outcome measures

Outcome measures
Measure	Zoledronic Acid n=34 Participants Patients who had greater than 4 disseminated tumor cells (DTCs)/mL present following neoadjuvant or adjuvant chemotherapy for early stage breast cancer were treated with 4mg zoledronic acid each month for 24 months.
Number of Patients With Incidences of Distant Recurrence	6 participants

Adverse Events

Zoledronic Acid

Serious events: 1 serious events

Other events: 33 other events

Deaths: 2 deaths

Serious adverse events

Serious adverse events
Measure	Zoledronic Acid n=45 participants at risk Patients who had greater than 4 disseminated tumor cells (DTCs)/mL present following neoadjuvant or adjuvant chemotherapy for early stage breast cancer were treated with 4mg zoledronic acid each month for 24 months.
Gastrointestinal disorders appendicitis	2.2% 1/45 • Two years

Other adverse events

Other adverse events
Measure	Zoledronic Acid n=45 participants at risk Patients who had greater than 4 disseminated tumor cells (DTCs)/mL present following neoadjuvant or adjuvant chemotherapy for early stage breast cancer were treated with 4mg zoledronic acid each month for 24 months.
Musculoskeletal and connective tissue disorders Myalgia	40.0% 18/45 • Two years
Musculoskeletal and connective tissue disorders Back pain	4.4% 2/45 • Two years
Musculoskeletal and connective tissue disorders Bone pain	8.9% 4/45 • Two years
Respiratory, thoracic and mediastinal disorders Cough	2.2% 1/45 • Two years
General disorders Fatigue	31.1% 14/45 • Two years
General disorders Fever	11.1% 5/45 • Two years
General disorders Flu like symptoms	22.2% 10/45 • Two years
Gastrointestinal disorders grinding teeth	2.2% 1/45 • Two years
Nervous system disorders Headache	2.2% 1/45 • Two years
Musculoskeletal and connective tissue disorders Hip pain	2.2% 1/45 • Two years
Investigations Creatinine increased	2.2% 1/45 • Two years
Musculoskeletal and connective tissue disorders Jaw pain	2.2% 1/45 • Two years
Musculoskeletal and connective tissue disorders Arthralgia	4.4% 2/45 • Two years
Nervous system disorders Lightheadedness	4.4% 2/45 • Two years
Gastrointestinal disorders Nausea	6.7% 3/45 • Two years
Skin and subcutaneous tissue disorders Rash	2.2% 1/45 • Two years
Injury, poisoning and procedural complications Soreness at infusion site	2.2% 1/45 • Two years
Gastrointestinal disorders Vomiting	4.4% 2/45 • Two years

Additional Information

Hope S. Rugo

UCSF Helen Diller Family Comprehensive Cancer Center

Phone: 415-353-7618

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place