Phase II randomized clinical trial to investigate efficacy of zoledronic acid for the patients with metastatic or advanced breast cancer

Phase II randomized clinical trial to investigate efficacy of zoledronic acid for the patients with metastatic or advanced breast cancer - Randomized clinical trial to investigate efficacy of zoledronic acid for the patients with metastatic or advanced breast cancer

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000027382

Enrollment

Registered

2017-05-19

Start date

2010-02-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Metastatic breast cancer

Interventions

Zoledronic acid + standard chemotherapy Standard chemotherapy

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: 1) histologically or cytologically proven breast cancer 2) HER-2 negative breast cancer 3) Stage IV or recurrent breast cancer 4) No evidence of bone metastasis 5) There is a lesion to be evaluated by RECIST

Exclusion criteria

Exclusion criteria: 1) There is any infection or complication of teeth 2) History of allergy by zoledronic acud 3) Patients with osteoporosis who needs therapy by bisphosphonates

Design outcomes

Primary

Measure	Time frame
Progression free survival, PFS	—

Secondary

Measure	Time frame
Response rate, RR clinical benefit rate (after 24 weeks) Skeletal related events, SRE Time to bone metastasis	—

Countries

Japan

Contacts

Public ContactSyusyu Mitsuyama

Kyushu Breast Cancer Study Group (KBC-SG) Oncology, hematology and infectious medicine, Fukuoka University Faculty of Medicine

npo@chotsg.com0928012845

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026