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Comparative Study of Neoadjuvant Chemotherapy With and Without Zometa for Management of Locally Advanced Breast Cancers

Phase 2
18 Years
Open (Enrolling)
Locally Advanced Breast Cancer, Ductal Histologic Type, Without Her2 Overexpression.

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Trial Information

Comparative Study of Neoadjuvant Chemotherapy With and Without Zometa for Management of Locally Advanced Breast Cancers

Inclusion Criteria:

- Women 18 years of age or older

- Absence of contraindication to treatment with Zometa: creatinine clearance greater
than 30 mL/min (with Cockroft or MDRD method).

- Breast cancer (TNM II b, IIIa,) 3 cm and larger in maximal diameter, able to benefit
from neoadjuvant chemotherapy

- Ductal histological type of the breast tumor

- WHO performance status 0-2

- Patient who understands the french language

- Covered by, or having the right to Social Security

- Signed informed consent

Exclusion Criteria:

- Breast cancers of other histological type other than ductal (lobular, tubular, ….)

- Noninvasive cancer

- Multifocal tumor (more than 2 tumoral lesions or 2 tumoral lesions distant more than
2cm each other)

- T4 breast tumor

- Presence of organ, bone, or skin metastases (in the initial staging workup)

- Her2 overexpression (by IHC or FISH)

- Patient with a history of breast cancer

- Other cancer currently in treatment (except carcinoma in situ).

- Severe systemic disease potentially interfering with follow-up.

- Contraindication to injected products: known allergy to bisphosphonates, zoledronic
acid or excipients, severe renal failure (creatinine clearance < 30 mL/min with
Cockroft or MDRD method).

- Women who are pregnant (positive pregnancy test) or breast-feeding, or absence of
contraception in a woman who is able to become pregnant.

- Patient with current dental problems, including dental infection or infection of the
jaw, intrabuccal exposure of jawbone, and history or current diagnosis of
osteonecrosis of the jaw.

- Prior treatment with bisphosphonates (either IV or oral).

- History of severe bone disease (severe osteoporosis with multiple skeletal-related

Type of Study:


Study Design:

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

Outcome Measure:

Decrease in serum VEGF concentration treatment

Outcome Description:

To assess the improvement obtained by adding Zometa treatment to neoadjuvant chemotherapy in patients with locally advanced breast cancer on concentrations of serum VEGF (neoangiogenesis marker and prognostic factor) before treatment and during surgery after neoadjuvant treatment (i.e., at about 8 months)

Outcome Time Frame:

8 months

Safety Issue:



France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Study ID:




Start Date:

April 2010

Completion Date:

November 2013

Related Keywords:

  • Locally Advanced Breast Cancer
  • Ductal Histologic Type
  • Without Her2 Overexpression.
  • locally advanced breast cancer
  • neoadjuvant chemotherapy
  • HER2-negative breast cancer
  • stage IIb breast cancer
  • stage IIIa breast cancer
  • Zoledronic acid
  • bisphosphonate
  • zometa
  • therapeutic response
  • VEGF serum
  • tumors markers
  • neoangiogenesis
  • apoptosis
  • proliferation
  • disseminated tumors cells
  • gamma-delta T cells activation
  • Breast Neoplasms