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Influence of Zoledronic Acid on Bone Mineral Density and Bone Ultrasonometry in Premenopausal Women With Hormone Receptor Negative Breast Cancer and Adjuvant Chemotherapeutic Treatment


Phase 4
18 Years
N/A
Open (Enrolling)
Female
Primary Hormone Receptor Negative Breast Cancer in Premenopausal Women

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Trial Information

Influence of Zoledronic Acid on Bone Mineral Density and Bone Ultrasonometry in Premenopausal Women With Hormone Receptor Negative Breast Cancer and Adjuvant Chemotherapeutic Treatment


Inclusion Criteria:



- Female patients with histologically confirmed incident invasive breast cancer (T1-4)
with no evidence of regional lymph node metastasis (N0) or distant metastasis (M0)
and after complete primary tumor resection and axillary lymph node dissection less
than 90 days before start of study drug treatment.

- Hormone receptor status is negative

- Patient is premenopausal (spontaneous and regular menses with premenopausal estradiol
levels (>10ng/dL)

- Patient receives adjuvant standard chemotherapy with approved cytotoxic
chemotherapeutic drugs (e.g. AC 4-6 cycles) (prior neoadjuvant CT is allowed)

- Bone density at study entry > -2.5 T-Score

Exclusion Criteria:

- Prior treatment with bisphosphonates and estrogens or treatments for osteoporosis in
addition to calcium and vitamin D

- Severe physical or psychological concomitant diseases and other known concurrent,
severe medical disorder jeopardizing the life of the patient in the immediate future
(e.g., myocardial infarction in previous six months, angina pectoris despite
treatment, uncontrolled severe arterial hypertension, progressive cardiac or
respiratory failure)

- Known hypersensitivity to bisphosphonates

- Abnormal renal function

- Current active dental problems including infection of the teeth or jawbone (maxilla
or mandibular); dental or fixture trauma, or a current or prior diagnosis of
osteonecrosis of the jaw (ONJ), of exposed bone in the mouth, or of slow healing
after dental procedures and recent (within 6 weeks) or planned dental or jaw surgery
(e.g. extraction, implants)

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

Change in bone mineral density (BMD) measured by DXA at lumbar spine (L2-L4) between baseline and 24 months.

Outcome Time Frame:

2 years

Safety Issue:

No

Principal Investigator

Novartis Pharmaceuticals

Investigator Role:

Study Director

Investigator Affiliation:

Novartis Pharmaceuticals

Authority:

United States: Food and Drug Administration

Study ID:

CZOL446GDE13

NCT ID:

NCT00333229

Start Date:

March 2006

Completion Date:

December 2013

Related Keywords:

  • Primary Hormone Receptor Negative Breast Cancer in Premenopausal Women
  • Breast Cancer
  • premenopausal
  • Bone Mineral density
  • Cancer therapy induced bone loss
  • zoledronic acid
  • Breast Neoplasms

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