Open-label, single arm, phase II study for evaluation of complete response rate at surgery after NEOadjuvant treatment with SUnitinib and docetaxel in patients with newly diagnosed large operable or locally advanced breast cancer - NEOS

• Conditions: large operable and locally advanced breast cancer; MedDRA version: 9.1Level: LLTClassification code 10006187Term: Breast cancer

• Registration Number: EUCTR2007-007257-31-PT
• Lead Sponsor: IPOLFG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-01-28
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: 30

Inclusion Criteria

1. Histologically or cytologically proven newly diagnosed untreated invasive breast cancer
(independent of ER, PgR and Her2 status), existence of a tumour greater than 3 cm in diameter
by caliper measurement and/or N2-3 disease with a palpable breast mass.
2. Indication for neoadjuvant chemotherapy as judged by the institutional multidisciplinary
conference (large operable tumour aiming at breast conservation, locally advanced or
inflammatory disease).
3. Multifocal and multicentric breast tumours are allowed as long as only two tumour foci are
identified, since two sequential tumour samples are to be collected from each tumour focus.
4. Consent to perform two core biopsies: one immediately before sunitinib administration and
another after the two weeks of the first course of sunitinib treatment.
5. Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and
other study procedures.
6. Adequate organ function
7. Female, 18 years of age or older.
8. ECOG performance status 0, 1 or 2.
10. Signed and dated informed consent document indicating that the patient (or legally
acceptable representative) has been informed of all the pertinent aspects of the trial prior to
enrolment.
11. Consent to undergo breast cancer surgery at day 113.
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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Diagnosis of any second malignancy within the last 3 years, except for adequately treated
basal cell carcinoma or squamous cell skin cancer or in situ carcinoma of the cervix uteri.
2. Prior treatment for cancer, including systemic chemo or endocrine therapy, surgery or
radiation, tyrosine kinase inhibitors or antiangiogenic therapy.
3. Metastatic breast cancer.
4. Patients for whom docetaxel is contraindicated according to the local prescribing
information.
5. History of severe hypersensitivity reactions to docetaxel or to other drugs formulated with
polysorbate 80.
6. Major surgery, radiation therapy, or systemic therapy within 3 weeks of start of study
treatment.
7. Prior radiation therapy to >25% of the bone marrow (whole pelvis is 25%).
8. Current treatment on another clinical trial.
9. Any of the following within the 12 months prior to starting study treatment: myocardial
infarction, severe/unstable angina, coronary/peripheral artery bypass graft, congestive heart
failure, cerebrovascular accident including transient ischemic attack, or pulmonary embolus.
10. Ongoing cardiac dysrhythmias of grade =2, atrial fibrillation of any grade, or QTc interval
>470 msec.
11. Hypertension that cannot be controlled by medications (>150/100 mmHg) despite optimal
medical therapy).
12. Current treatment with therapeutic doses of warfarin (low dose warfarin up to 2 mg PO daily
for deep vein thrombosis prophylaxis or i.v. catheter patency is allowed).
13. Known human immunodeficiency virus infection.
14. Pregnancy or breastfeeding.
15. Female of child-bearing potential that is unwilling or unable to use adequate contraception
to prevent pregnancy during the program, (all female patients with reproductive potential must
have a negative pregnancy test (serum or urine) prior to study entry).
16. Other severe acute, chronic medical, psychiatric condition, or laboratory abnormality that
would impart, in the judgment of the investigator, excess risk associated with study participation
or study drug administration, or which, in the judgment of the investigator, would make the
patient inappropriate for entry into this study.

Study & Design

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