Status:
TERMINATED
Phase II Trial to Validate Markers for a Response Evaluation of a Combined Therapy in Patients With HER2+ Breast Cancer
Lead Sponsor:
West German Study Group
Collaborating Sponsors:
GlaxoSmithKline
Conditions:
Carcinoma, Ductal, Breast
Eligibility:
FEMALE
18-75 years
Phase:
PHASE2
Brief Summary
The Neo-PREDICT-HER2 Study is phase II trial to validate predictive markers for the response evaluation of a combined chemo-immunotherapy in patients with HER2-positive early breast cancer. The only t...
Detailed Description
Trastuzumab (T)-containing neoadjuvant chemotherapy has been reported to increase the probability of pathological complete response (pCR) in HER2 positive disease up to 67 %. Large trials revealed pCR...
Eligibility Criteria
Inclusion
- Female patients, age at diagnosis 18 - 75 years
- Histological confirmed unilateral primary invasive carcinoma of the breast
- Clinical Stage Tumor 1 (cT1) (\> 1 cm) - Clinical Stage Tumor 4 (cT4) (if operable, inflammatory breast cancer is excluded)
- HER2 over-expressing tumor confirmed by: 3+ by Immuno-histochemistry (IHC) and/or HER2/neu gene amplification by fluorescence, chromogenic or silver in-situ hybridization \[Fluorescent In-Situ Hybridization (FISH), Chromogenic In-Situ Hybridization (CISH) or Silver In-Situ Hybridization (SISH); \> 6 HER2 gene copies per nucleus or a FISH, CISH or SISH test ratio (HER2 gene copies to chromosome 17 signals) of ≥ 2.0\]
- Clinically node positive disease or node negative disease
- No clinical evidence for distant metastasis (cM0) after conventional staging
- Performance Status Eastern Cooperative Oncology Group (ECOG) ≤ 1 or Karnofsky Index (KI) ≥ 80%
- Baseline Left Ventricular Ejection Fraction (LVEF) \> 50% measured by echocardiography
- Negative pregnancy test (urine or serum) within 7 days prior to start of induction treatment in premenopausal patients
- The patient must be accessible for treatment and follow-up
- Written informed consent including a written informed consent for shipping of tumor block for central pathology review and evaluation prior to the start of any study procedures
Exclusion
- Known hypersensitivity reaction to the compounds or incorporated substances
- Known polyneuropathy grade ≥ 2
- Have acute or currently active or requiring anti-viral therapy hepatic or biliary disease (with exception of patients with Gilbert's syndrome, asymptomatic gallstones, stable chronic liver disease per investigator assessment).
- Prior malignancy with a disease-free survival of \< 10 years, except curatively treated basalioma of the skin, pTis of the cervix uteri
- Prior or concurrent treatment with cytotoxic agents for any reason after consultation with the sponsor
- Concurrent treatment with other experimental drugs. Participation in another clinical trial with any investigational not marketed drug within 30 days prior to study entry
- Male breast cancer
- Concurrent pregnancy; patients of childbearing potential must implement a highly effective (less than 1% failure rate) non-hormonal contraceptive measures during the study treatment
- Breast feeding women
- Sequential breast cancer
- Lack of patient compliance
- Inadequate organ function including:
- Leucocytes \< 3.5 x 109/l
- Platelets \< 100 x 109/l
- Absolute Neutrophil Count (ANC) \< 1.5 x 109/l
- Hemoglobin \< 9 g/dl
- Serum Creatinine \> 1.5 mg/dl
- Serum Bilirubin \> 1.1 mg/dl
- Alkaline phosphatase \> 2.5 x Upper Limit of Normal (ULN)
- Aspartate Transaminase (ASAT) and/or Alanine Transaminase (ALAT) \> 2.5 ULN
- Albumin \< 2.5 g/dl
- Uncompensated cardiac function
- Malabsorption syndrome, disease significantly affecting gastrointestinal function
- Concomitant use of Cytochrome P450 3A4 (CYP3A4) inhibitors or inducers
Key Trial Info
Start Date :
September 30 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 16 2016
Estimated Enrollment :
64 Patients enrolled
Trial Details
Trial ID
NCT01891357
Start Date
September 30 2013
End Date
November 16 2016
Last Update
September 17 2019
Active Locations (10)
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1
Klinikum Esslingen
Esslingen am Neckar, Baden-Wurttemberg, Germany, 73730
2
SLK Kliniken
Heilbronn, Baden-Wurttemberg, Germany, 74078
3
Klinikum Frankfurt Höchst
Frankfurt am Main, Hesse, Germany, 65929
4
Niels-Stensen-Kliniken
Georgsmarienhütte, Lower Saxony, Germany, 49124