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Neoadjuvant Therapy for Postmenopausal Women With ER and/or PgR Positive Breast Cancer. A Randomized Open Phase II Trial Evaluating the Efficacy of a 6 Months Preoperative Treatment With Letrozole (2.5 mg/Day) With or Without Zoledronic Acid (4 mg Every 4 Weeks)


Phase 2/Phase 3
N/A
N/A
Open (Enrolling)
Female
Breast Neoplasms

Thank you

Trial Information

Neoadjuvant Therapy for Postmenopausal Women With ER and/or PgR Positive Breast Cancer. A Randomized Open Phase II Trial Evaluating the Efficacy of a 6 Months Preoperative Treatment With Letrozole (2.5 mg/Day) With or Without Zoledronic Acid (4 mg Every 4 Weeks)

Inclusion Criteria


Inclusion criteria:

- Postmenopausal women with primary invasive breast cancer, histologically confirmed by
core needle biopsy, whose tumors are estrogen (ER) and / or progesterone (PgR)
positive

- Clinical Stage T1c (Size ≥ 1.5 cm), T2, T3, T4a, b, c, N0 or N1, M0 (TNM
Classification). According to the modified RECIST criteria, tumors of size ≥ 1.5 cm
are considered measurable by mammography and can be determined as target lesions).

- Tumor measurable by mammography, sonography and clinical examination.

- Adequate bone marrow, renal and hepatic function

- Good health status (ECOG Performance status of 0, 1 or 2)

Exclusion criteria:

- Prior treatment with letrozole or bisphosphonates. Prior and concomitant
anti-breast-cancer treatments such as chemotherapy, immunotherapy / biological
response modifiers (BRM's), endocrine therapy other than letrozole (including
steroids), and radiotherapy. Patients who have received hormone replacement therapy
(HRT) will NOT be excluded, provided that HRT is discontinued at least 2 weeks prior
to entry into the study.

- Patients with unstable angina, or uncontrolled cardiac disease (e.g. Class III and IV
New York Heart Association's Functional Classification, see Appendix 9) or
uncontrolled endocrine disorders.

- Evidence of inflammatory breast cancer or distant metastasis.

- 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. Recent (within 6 weeks) or planned dental or jaw surgery
(e.g. extraction, implants).

- History of diseases with influence on bone metabolism, such as Paget's disease,
Osteogenesis Imperfecta, and primary or secondary hyperthyroidism within the 12
months prior to study entry

Other protocol-defined inclusion/exclusion criteria may apply

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Tumor Response Rate (Complete Response (CR) or Partial Response (PR)) Based on MRI- or Mammography and/or Sonography According to Modified RECIST Criteria at Month 6

Outcome Description:

Sum of longest diameter for all target lesions was reported as baseline sum LD. Baseline sum LD was used as reference to characterize objective tumor response. Response Evaluation Criteria in Solid Tumors has 4 response categories. CR (complete response) = disappearance of all target lesions, PR (partial response)= 30% decrease in sum of longest diameter of target lesions, PD (progressive disease) = 20% increase in the sum of the longest diameter of target lesions and SD(stable disease)=small changes that do not meet criteria. Analysis was underpowered due to insufficient recruitment rate.

Outcome Time Frame:

6 months

Safety Issue:

No

Principal Investigator

Novartis Pharmaceuticals

Investigator Role:

Study Director

Investigator Affiliation:

Novartis Pharmeceuticals

Authority:

Germany: Federal Institute for Drugs and Medical Devices

Study ID:

CZOL446GDE19

NCT ID:

NCT00375752

Start Date:

May 2006

Completion Date:

December 2013

Related Keywords:

  • Breast Neoplasms
  • Breast cancer
  • Anti tumor potential
  • Letrozole
  • Zoledronic acid
  • Neoadjuvant treatment
  • Hormone responsive breast cancer
  • Breast Neoplasms
  • Neoplasms

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