ZoNantax - Zolendronic Acid as Neoadjuvant Therapy Plus Anthracycline and Taxane in Locally Advanced Breast Cancer
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Purpose
The purpose of this study is to evaluate the association of zoledronic acid with standard treatment with anthracycline followed taxane plus trastuzumab in locally advanced breast cancer HER 2 positive.
| Condition | Intervention | Phase |
|---|---|---|
|
Breast Cancer Breast Disease Neoplasms Neoplasms by Site |
Drug: cyclophosphamide, Adriamycin, Docetaxel, Trastuzumab, Zolendronic acid |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Phase II Clinical Trial of Neoadjuvant Treatment With Zolendronic Acid Plus Anthracycline and Taxane in Locally Advanced Breast Cancer |
- Evaluate the residual cancer burden (RCB) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- Assessing the tolerance to standard neoadjuvant treatment plus zolendronic acid,according to the common toxicity criteria Terminology Criteria for Adverse Events version 3.0. [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
- Assessment of the difference in gene expression according to treatment response [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- Prediction of pathological response by MRI calculated from the sequence of apparent diffusion coefficient (ADC) [ Time Frame: 4 months ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 56 |
| Study Start Date: | October 2011 |
| Estimated Study Completion Date: | November 2014 |
| Estimated Primary Completion Date: | August 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Zometa neoadjuvant HER2 breast cancer
Association of zoledronic acid with standard treatment with anthracycline followed taxane plus trastuzumab in locally advanced breast cancer HER2 positive. Drug:Cyclophosphamide Drug:Adriamycin Drug:Docetaxel Drug:Trastuzumab Drug:Zolendronic acid |
Drug: cyclophosphamide, Adriamycin, Docetaxel, Trastuzumab, Zolendronic acid
Experimental: AC,Docetaxel,Trastuzumab,Zolendronate Drug: AC Adriamycin 60mg/m2 IV plus cyclophosphamide 600mg/m2 every 21 days for 4 cycles Drug: Docetaxel Docetaxel 100 mg/m2 every 21 days for 4 cycles. Drug: Trastuzumab Trastuzumab 8mg/kg [loading dose] once then 6mg/kg IV every 21 days for 3 cycles plus docetaxel. Drug: zolendronic acid Zolendronic acid 4mg IV every 21 days for 8 cycles combine with chemotherapy Other Names:
|
Detailed Description:
This trial combines zolendronic acid with anthracycline followed taxane plus trastuzumab for neoadjuvant treatment of HER 2 positive stage II/III breast cancer.
Zoledronic acid (ZOL) has activity of anti-bone resorption and shows diverse anti-tumor effects in vitro. Some chemical and biological characteristics of ZOL indicate potential for inhibition of tumor growth in pre clinical studies
The primary objective of the study is to evaluate the residual cancer burden (RCB) with the addition of zolendronic acid to standard neoadjuvant therapy. RCB is calculated as a continuous index combining pathologic measurements of primary tumor (size and cellularity) and nodal metastases (number and size). RCB index is a significant predictor of distant relapse-free survival, and can be used to define categories of near-complete response and chemotherapy resistance after neoadjuvant chemotherapy compared with currently used risk factors. Additionally, the study will collect tissue biopsies and blood before and after treatment in order to correlate clinical outcomes with gene expression and radiologic data to predictive response.
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Stage IIA to IIIB HER-2 positive breast cancer
- ECOG performance ≤ 2
Adequate hematologic function with:
- Absolute neutrophil count (ANC)> 1500/mm³
- Platelets ≥ 100.000/mm³
- hemoglobin ≥ 9g/dL
Adequate hepatic and renal function with:
- Serum bilirubin ≤ 1.5 x the institutional upper limit of normal (ULN)
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT)≤ 2.5 x the institutional upper limit of normal (ULN)
- Alkaline phosphatase )≤ 2.5 x the institutional upper limit of normal (ULN)
- Serum creatinine ≤ 1.5 x the institutional upper limit of normal (ULN) or calculated creatinine clearance > 50 mL/min
Adequate cardiac function
- Left ventricular ejection fraction (LVEF)with institutional normal range
- Knowledge of the investigational nature of the study and ability to provide consent for study participation
Exclusion Criteria:
- Previous diagnostic of breast or other cancer
- Pregnancy
- Metastatic breast cancer
- Bilateral, synchronous breast cancer
- Any other disease(s), psychiatric condition, metabolic dysfunction, that contraindicates the use of study drugs or that woud make the patient inappropriate for this study
- Neuropathy grade > 2 by the Common Terminology Criteria for Adverse Events version 3.0 (CTCAE v3.0)
Contacts and Locations| Contact: Susanne C Costa, MD | 55 21 32073954 | crocamo@inca.gov.br |
| Contact: Roberta M Sarmento, RN | 55 21 32073819 | rsarmento@inca.gov.br |
| Brazil | |
| Hospital do Cancer III - INCA | Recruiting |
| Rio de Janeiro, Brazil, 20560-120 | |
| Contact: Susanne C Costa, MD 55 21 32073954 crocamo@inca.gov.br | |
| Contact: Roberta M Sarmento, RN 55 21 32073810 rsarmento@inca.gov.br | |
| Principal Investigator: Susanne C Costa, MD | |
| Principal Investigator: | Susanne C Costa, MD | Hospital do Cancer III - INCA |
More Information
No publications provided
| Responsible Party: | Susanne Crocamo, Clinical Oncologist, Instituto Nacional de Cancer, Brazil |
| ClinicalTrials.gov Identifier: | NCT01472146 History of Changes |
| Other Study ID Numbers: | Zo-neo2011 |
| Study First Received: | September 20, 2011 |
| Last Updated: | March 4, 2013 |
| Health Authority: | Brazil: Ministry of Health |
Keywords provided by Instituto Nacional de Cancer, Brazil:
|
Neoadjuvant therapy Breast cancer HER2 positive zolendronic acid |
Additional relevant MeSH terms:
|
Breast Neoplasms Breast Diseases Neoplasms Neoplasms by Site Skin Diseases Cyclophosphamide Docetaxel Trastuzumab Doxorubicin Immunosuppressive Agents Immunologic Factors |
Physiological Effects of Drugs Pharmacologic Actions Antirheumatic Agents Therapeutic Uses Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Myeloablative Agonists Antibiotics, Antineoplastic |
ClinicalTrials.gov processed this record on May 19, 2013