XINACT: To evaluate the benefit of specific drug combinations in reducing cancer tissue in the breast in women who have large breast cancers but confined to the breast and draining lymph glands.

• Conditions: arge (>/=3 cm) or locally advanced breast cancers; MedDRA version: 14.1Level: PTClassification code 10057654Term: Breast cancer femaleSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2007-003221-25-GB
• Lead Sponsor: nited Lincolnshire Hospitals NHS Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-07-31
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Female
• Target Recruitment: 120

Inclusion Criteria

1. Women with histologically confirmed carcinoma of the breast, with measurable or evaluable large (= 3cm) or locally advanced (T3, T4, TxN2) disease
2. Women who are over 18 and under 75 years and able to sign the informed consent
3. Ability to comply with study and follow-up procedures
4. Adequate left ventricular function at study entry, defined as LVEF = 50% by echocardiography (ECHO)

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 90
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 25

Exclusion Criteria

1. WHO performance status 2, 3 and 4
2. Prior chemotherapy or radiotherapy unless for basal cell carcinoma
3. Unstable angina and/or evidence of significant cardiac dysfunction
4. Patients who have diabetes requiring insulin
5. Pregnancy or lactation
6. Inadequate organ function, as evidenced by any of the following laboratory values: Absolute neutrophil count < 1500/uL; Platelet count < 100,000/uL; Total bilirubin > 1.5 mg/dL; Alkaline phosphatase, AST, and/or ALT > 2x upper limit of normal; Serum creatinine > 2.0 mg/dL; PTT and/or either INR or PT > 1.5x upper limit of normal (except for subjects receiving anti-coagulation therapy); Urine protein/creatinine ratio > 1.0 at screening
7. Inability to complete Quality of Life questionnaires

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified