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
events).