Multicenter phase II trial to assess clinical benefit of zoledronic acid with neo adjuvant endocrine treatment and the relationship between zoledronic acid use and gammadelta T cells for postmenopausal breast cancer.

Multicenter phase II trial to assess clinical benefit of zoledronic acid with neo adjuvant endocrine treatment and the relationship between zoledronic acid use and gammadelta T cells for postmenopausal breast cancer. - A phase II study whether zoledronic acid with neoadjuvant endocrine therapy is more effectvely related to gammadelta T cells.

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000008701

Enrollment

Registered

2012-11-01

Start date

2013-08-01

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

Postmenopausal ER positive and HER2 negative primary breast cancer

Interventions

letrozole plus zoledronic acid

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: 1) Primary breast cancer with T1-2 stage without any metasitasis (cT1-2cN01cM0), 2) Invasive ducaal carcinoma 3)ER positive and HER2 negative: the results of IHC test can be negative or 1+ or 2+ and FISH negative 4) Age >=60, postmenopausal 5 years, the patients who had bilateral oophorectomy. 5)No prior treatment for breast cancer, 6) Performance status 0-1, 7) Patients have a measurable lesion on enhanced MRI within 6 weeks before entru of study.

Exclusion criteria

Exclusion criteria: 1)Hyperparathyroidism requires for treatment, Uncontrolled diabetes mellitus, Disease requires continuous and systemic administration of steroid hormone, Dental and/or periodontal disease which requires invasive treatment after registration. 2)Synchronous double cancer, Met asynchronous double cancer diagnosed in 5 years (excluding basal cell carcinoma, carcinoma in situ, superficial bladder cancer, neoplasms cured by endoscopic surgery)3)Prior treatament with bisphosphonates 4)Patients who have received hormone replacement therapy ( If HRP is stopped more than 7 days prior to study entry, they meet registration criteria.) 5)Hypersensitivity to contrast materials for MRI 6)Use of other investigational drugs in 28 days prior to study entry 7)Patients who are judged inappropriate for the clinical trial by doctors

Design outcomes

Primary

Measure	Time frame
Response	—

Secondary

Measure	Time frame
Change of tumor volume on MRI volumetry. Tumor response assessed by caliper and US. Induction and activation of gammadelta T cells. PEPI socore and Ki67 after treatment	—

Countries

Japan

Contacts

Public ContactTomoharu Sugie

Graduate School of Medicie, Kyoto University Breast Surgery

Outcome results

None listed

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