Trastuzumab in a Neo-adjuvant Regimen for HER2+ Breast Cancer - the TRAIN Study

NCT00768859 | Completed Phase 2 DMC

• 2 other identifiers: M08TRA2008-000987-18
• Study Type: interventional
• Target: 111
• Locations: 1 country
• Sites: 9

Brief Summary

To determine the activity of the combination of paclitaxel, trastuzumab and carboplatin as neo-adjuvant treatment in patients with stage II or III HER2 positive breast cancer

Conditions

Breast Cancer; HER2 Positive

Keywords

breast cancer; HER2 positive; neo-adjuvant; trastuzumab; paclitaxel; carboplatin

Outcome Measures

Primary Outcomes (1)

• Pathologic complete response (pCR) rate at surgery

  at the completion of neo-adjuvant chemotherapy

Secondary Outcomes (1)

• To describe disease-free and overall survival

  during routine follow up visits after surgery

Study Arms (1)

1

EXPERIMENTAL

paclitaxel, trastuzumab and carboplatin

Drug: paclitaxel, trastuzumab and carboplatin

Interventions

paclitaxel, trastuzumab and carboplatin DRUG

paclitaxel; 70 mg/m2 trastuzumab; 2 mg/kg (loading dose 4 mg/kg) carboplatin; AUC = 3

1

Eligibility Criteria

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

You may qualify if:

• Histologically or cytologically confirmed infiltrating breast cancer.
• Stage II or stage III breast cancer.28 'Locally advanced breast cancer' patients are consequently eligible, including those with ipsilateral supraclavicular lymph node metastases. N1 status must have been demonstrated by either fine needle aspiration from an axillary lymph node or by a metastasis of \>2 mm in diameter at sentinel node biopsy. Stage IIA patients are eligible if the tumor is \>3 cm in diameter or if the tumor is between 2 and 3 cm in diameter but a breast conserving surgery is not possible.
• Overexpression and/or amplification of HER2 in an invasive component of the core biopsy, according to one of the following definitions:
• \>10% of invasive tumor cells showing strong complete circumferential membrane staining (score 3+)
• \>10% of invasive tumor cells showing moderate complete circumferential membrane staining (score 2+) and demonstrating HER2 gene amplification defined as a FISH ratio of HER2 gene copies to chromosome 17 signals of \>2.2. or as \>5 HER2 gene copies per nucleus in CISH analysis.
• Patients with a negative or equivocal overall result (FISH test ratio of \<2.2, \<6.0 HER2 gene copies per nucleus) and staining scores of 0,1+, 2+ or 3+ (in 30% or less neoplastic cells) by IHC are not eligible for participation in the trial.
• Age ≥18
• Eastern Cooperative Oncology Group (ECOG) performance status ≤1 (Appendix B)
• Adequate bone marrow function (ANC \>1.0 x 109/l, platelets \>100 x 109/l)
• Adequate hepatic function (ALAT, ASAT and bilirubin \<2 times upper limit of normal)
• Adequate renal function (creatinine clearance \>60 ml/min)
• LVEF ≥50% measured by echocardiography or MUGA
• Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule
• Signed written informed consent

You may not qualify if:

• No previous radiation therapy or chemotherapy
• No other malignancy except carcinoma in situ, unless the other malignancy was treated ≥5 years ago with curative intent without the use of chemotherapy or radiation therapy.
• No current pregnancy or breastfeeding. Women of childbearing potential must use adequate contraceptive protection.
• No evidence of distant metastases. Staging examinations must have included a chest radiograph, an ultrasound examination of the liver and an isotope bone scan. Abnormal uptake on the isotope bone scan can only be accepted if MRI, CT-scan, or plain radiograph excludes bone metastases.
• No concurrent anti-cancer treatment or another investigational drug

Sponsors & Collaborators

• The Netherlands Cancer Institute: lead

Study Sites (9)

Medisch Centrum Alkmaar

Alkmaar, 1800 AM, Netherlands

Location

NKI-AVL

Amsterdam, 1066 CX, Netherlands

Location

Onze Lieve Vrouwe Gasthuis

Amsterdam, 1091 HA, Netherlands

Location

Reinier de Graaf Gasthuis

Delft, 2600 AG, Netherlands

Location

Catharina Ziekenhuis

Eindhoven, 5602 ZA, Netherlands

Location

Kennemer Gasthuis

Haarlem, 2035 RC, Netherlands

Location

Leids Universitair Medisch centrum

Leiden, 2300 RC, Netherlands

Location

Medisch Centrum Haaglanden

Leidschendam, 2262 BA, Netherlands

Location

Sint Antonius Ziekenhuis

Nieuwegein, 3430 EM, Netherlands

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Paclitaxel; Trastuzumab; Carboplatin

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Coordination Complexes

Study Officials

• G S Sonke, MD

  NKI-AvL

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: October 7, 2008
• First Posted: October 8, 2008
• Study Start: September 1, 2008
• Primary Completion: August 1, 2011
• Study Completion: May 1, 2012
• Last Updated: May 11, 2012

Record last verified: 2012-05

Locations

NL (9)