Evaluation of Chemotherapy Prior to Surgery With or Without Zometa for Women With Locally Advanced Breast Cancer

NCT00242203 | Completed Phase 2 DMC

• 1 other identifier: 02-0788 / 201104272
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

This study is designed to evaluate the impact of Zometa on clearance of bone marrow micrometastases; the protective effect on chemotherapy-induced loss of bone mineral density; and quality of life in women undergoing treatment for locally advanced breast cancer.

Conditions

Breast Neoplasms

Keywords

Breast Cancer; Neoadjuvant; Micrometastasis

Outcome Measures

Primary Outcomes (2)

• Evaluate the impact of Zometa (zoledronic acid) on the clearance of bone marrow micrometastases

  Prior to therapy initiation, after completion of neoadjuvant chemotherapy, and 12-15 months from registration

• Evaluate the protective effect of Zometa (zoledronic acid) on chemotherapy-induced loss of bone mineral density

  Prior to therapy initiation and 12-15 months from registration

Secondary Outcomes (2)

• Impact of Zometa (zoledronic acid) on time and site of relapse

  5 years from registration

• Effect of treatment on quality of life in women undergoing treatment for LABC.

  Baseline and 12-15 months from registration

Study Arms (2)

Zometa

EXPERIMENTAL

Zometa 4 mg IV every 3 weeks for a total of 17 doses. The first treatment will be given at the time of the first chemotherapy treatment and will continue for approximately 1 year. Neoadjuvant therapy * Epirubicin 75 mg/m2 IV every 21 days for 4 cycles prior to surgery * Docetaxel 75 mg/m2 IV every 21 days for 4 cycles prior to surgery Surgery - modified radical mastectomy or breast conserving surgery with axillary lymph node dissection Adjuvant therapy * Epirubicin 75 mg/m2 IV every 21 days for 2 cycles * Docetaxel 75 mg/m2 IV every 21 days for 2 cycles * All patients who are found to be Her-2 overexpressing by 3+ by ICH for FSH will receive trastuzumab 6 mg/kg IV every 3 weeks for 1 year post surgery Radiation therapy - 50-60 Gy in 1.8-2.0 Gy daily fractions to the breast or chest wall. Internal mammary nodes, supraclavicular fossa nodes and axillary nodal basins will receive 45-50 Gy over 5-6 weeks

Drug: Zometa; Drug: Epirubicin; Drug: Docetaxel; Drug: Trastuzumab; Radiation: External beam radiation; Procedure: Modified radical mastectomy or breast conserving surgery with axillary lymph node dissection

No Zometa

ACTIVE COMPARATOR

Neoadjuvant therapy * Epirubicin 75 mg/m2 IV every 21 days for 4 cycles prior to surgery * Docetaxel 75 mg/m2 IV every 21 days for 4 cycles prior to surgery Surgery - modified radical mastectomy or breast conserving surgery with axillary lymph node dissection Adjuvant therapy * Epirubicin 75 mg/m2 IV every 21 days for 2 cycles * Docetaxel 75 mg/m2 IV every 21 days for 2 cycles * All patients who are found to be Her-2 overexpressing by 3+ by ICH for FSH will receive trastuzumab 6 mg/kg IV every 3 weeks for 1 year post surgery Radiation therapy - 50-60 Gy in 1.8-2.0 Gy daily fractions to the breast or chest wall. Internal mammary nodes, supraclavicular fossa nodes and axillary nodal basins will receive 45-50 Gy over 5-6 weeks

Drug: Epirubicin; Drug: Docetaxel; Drug: Trastuzumab; Radiation: External beam radiation; Procedure: Modified radical mastectomy or breast conserving surgery with axillary lymph node dissection

Interventions

Zometa DRUG

Also known as: Zoledronic acid

Zometa

Epirubicin DRUG

Also known as: Ellence

No Zometa; Zometa

Docetaxel DRUG

Also known as: Taxotere

No Zometa; Zometa

Trastuzumab DRUG

ONLY for patients that are Her-2 overexpressing by 3+ by ICH for FSH

Also known as: Herceptin

No Zometa; Zometa

External beam radiation RADIATION

No Zometa; Zometa

Modified radical mastectomy or breast conserving surgery with axillary lymph node dissection PROCEDURE

No Zometa; Zometa

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Newly diagnosed primary invasive ductal or invasive lobular breast adenocarcinoma
• Tumor classified as clinically large T2 (2-5 cm), T3, T4 or any T with N1, N2
• Prior malignancies: limited to curatively treated basal or squamous carcinoma of the skin or history of previous malignancies, treated and now \> 5 years disease free
• \>= 18 years of age
• Normal left ventricular function by echocardiogram or radioventriculogram
• Karnofsky Performance \>= 70

You may not qualify if:

• No evidence of distant metastasis present by CT, Bone scan, or physical exam
• If the bone scan or CT scans demonstrate indeterminate lesions, the nature of these lesions may be further clarified by additional testing such as PET or MRI
• No current treatment with Zometa or other bisphosphonates
• No serious functional disorders of the liver or kidneys:
• Serum Creatinine \<=2
• ALT/AST/ALK Phos \<= 1.5 x upper limit of institutional normal.
• Bili \<= 1.5 x upper limit of institutional normal.
• Currently not pregnant

Sponsors & Collaborators

• Washington University School of Medicine: lead
• Novartis: collaborator
• Pfizer: collaborator

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

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Related Links

• Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine

MeSH Terms

Conditions

Breast Neoplasms; Neoplasm Micrometastasis

Interventions

Zoledronic Acid; Epirubicin; Docetaxel; Trastuzumab; Mastectomy, Modified Radical; Mastectomy, Segmental

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Neoplasm Metastasis; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diphosphonates; Organophosphonates; Organophosphorus Compounds; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Doxorubicin; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Diterpenes; Terpenes; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Mastectomy, Radical; Mastectomy; Surgical Procedures, Operative

Study Officials

• Rebecca Aft, M.D., Ph.D.

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 17, 2005
• First Posted: October 19, 2005
• Study Start: October 1, 2002
• Primary Completion: August 1, 2007
• Study Completion: May 1, 2011
• Last Updated: August 13, 2013

Record last verified: 2013-08

Locations

US (1)