A randomised, multicenter, multinational Phase II study on trastuzumab plus docetaxel versus trastuzumab plus docetaxel plus pertuzumab versus trastuzumab plus pertuzumab versus pertuzumab and docetaxel in patients with locally advanced, inflammatory or early stage HER2 positive breast cancer.

Phase 1

• Conditions: ocally advanced, inflammatory or early stage HER2 positive breast cancer.; MedDRA version: 9.1 Level: LLT Classification code 10065430 Term: HER-2 positive breast cancer; MedDRA version: 9.1 Level: LLT Classification code 10021974 Term: Inflammatory breast cancer; MedDRA version: 9.1 Level: LLT Classification code 10006200 Term: Breast cancer stage II; MedDRA version: 9.1 Level: LLT Classification code 10006201 Term: Breast cancer stage III

• Registration Number: EUCTR2007-001105-13-GB
• Lead Sponsor: F. Hoffmann-La Roche Ltd, Pharmaceuticals Division, PDR

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2008-02-13
• Study Completion: 2014-09-22
• Last Update Posted: 30 June 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 417

Inclusion Criteria

1. Female patients =18 years with locally advanced, inflammatory or early
stage, unilateral and histologically confirmed invasive breast cancer.
2. Primary tumor >2cm in diameter.
3. HER2 positive confirmed by a central laboratory. Tumors must be HER2+++
by IHC or FISH/CISH + (FISH/CISH mandatory for HER2 ++ tumors).
4. Availability of FFPE tissue for central confirmation of HER2 eligibility (FFPE
tumor tissue will subsequently be used for assessing status of biomarkers).
6. Baseline LVEF of = 55% (measured by echocardiogram or MUGA).
7. Performance status ECOG Scale = 1.
8. At least 4 weeks since major unrelated surgery, with full recovery.
9. A negative pregnancy test must be available for pre-menopausal women and for
women less than 2 years after the onset of menopause.
10. Signed informed consent.

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. Metastatic disease (Stage IV) or bilateral breast cancer.
2. Previous anticancer therapy or radiotherapy for any malignancy.
3. Other malignancy, except for carcinoma in situ of the cervix or basal cell
carcinoma.
4. Inadequate bone marrow function (e.g. Absolute Neutrophil Count (ANC)
<1.5 x 1,000,000,000/L, Platelet count < 100 x 1,000,000,000/L and
Hb < 9 g/dL ).
5. Impaired liver function: (e.g. serum [total] bilirubin > 1.25 x ULN (with the
exception of Gilbert’s syndrome), AST, ALT > 1.25 x ULN, albumin < 25 g/L
6. Inadequate renal function, serum creatinine >1.5 x ULN.
7. Uncontrolled hypertension (systolic > 150 and/or diastolic > 100), unstable
angina, CHF of any NYHA classification, serious cardiac arrhythmia requiring
treatment (exception, atrial fibrillation, paroxysmal supraventricular tachycardia),
history of myocardial. infarction within 6 months of enrollment, or LVEF < 55%.
8. Dyspnea at rest or other diseases which requires continuous oxygen therapy.
9. Severe uncontrolled systemic disease (e.g. hypertension, clinically significant
cardiovascular, pulmonary, metabolic, wound-healing, ulcer, or bone fracture).
10. Subjects with insulin-dependent diabetes.
11. Pregnant and/or lactating women.
12. Subjects with reproductive potential not willing to use highly effective non-hormonal method of contraception or two effective forms of non-hormonal contraception. Contraception use must continue for the duration of study treatment and for at lest 6 months post discontinuation of study treatment. For details please see section 7.2.4.
13. Received any investigational treatment within 4 weeks of study start.
14. Subjects with known infection with HIV, HBV, HCV.
15. Known hypersensitivity to any of the study drugs or excipients.
16. Subjects assessed by the investigator to be unable or unwilling to comply with
the requirements of the protocol.

Study & Design

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