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Molecular Imaging for Response Assessment of Bevacizumab + Docetaxel as Neoadjuvant Chemotherapy in Primary Breast Cancer

Phase 2
18 Years
65 Years
Not Enrolling
Primary Breast Cancer

Thank you

Trial Information

Molecular Imaging for Response Assessment of Bevacizumab + Docetaxel as Neoadjuvant Chemotherapy in Primary Breast Cancer

Inclusion Criteria:

Arm A / Arm B

- Age ≥ 18 years and ≤ 65 years

- Female

- Operable, locally advanced primary breast cancer (≥ cT2, N0 or N+, M0)
histologically confirmed by core biopsy

- Histologically confirmed unilateral, solitaire breast cancer

- Patients who are candidates for neoadjuvant chemotherapy according to AGO guidelines
( with unifocal lesion

- HER2 positive disease (IHC 3+ and/or FISH positive)or

- HER2 negative disease (IHC 0/1+, IHC 2+ and/or FISH negative)

- Baseline LVEF ≥ 55% (measured by MUGA or echocardiography) according to institution
specific norm

- Informed consent for clinical trial including analysis of predictive imaging tests
and biomarkers

- Clinically or by imaging (mammogram, MRI or US) assessed breast cancer ≥ 2 cm or
inflammatory breast cancer with bi-dimensional measurable lesion independent of nodal

- Negative pregnancy test (urine or serum) within 7 days prior to registration if
patient is premenopausal with intact reproductive organs and if patient is less than
one year after menopause

- ECOG Performance status 0-2

- Adequate organ function for cytotoxic chemotherapy

- Adequate renal function including Serum creatinine ≤ ULN, Measured or calculated
creatinine clearance > 60 ml/min

- Urine dipstick for proteinuria < 2+. In case of ≥ 2+ proteinuria on dipstick
urinalysis, a 24-hour urine collection must be performed and protein per 24 hours
must be ≤ 1.0 g

- Absolute neutrophil count ≥ 1500 cells/μl, platelet count ≥ 100,000 cells/μl

- Bilirubin ≤ ULN; ALT or AST ≤ 1.5 x ULN, and alkaline phosphatase < 2.5 x ULN

- Patients must be available and compliant for treatment and follow-up

Exclusion Criteria:

Arm A / Arm B

- Evidence of distant metastases by clinical or imaging diagnosis

- Multifocal primary tumour, defined as histologically confirmed tumour-manifestations
within different quadrants; distance ≥ 4 cm

- Pre-existing motor or sensory neuropathy of a severity ≥ grade 2 NCI criteria

- Previous breast cancer

- Prior malignancy with a disease-free survival of < 5 years

- Prior malignancy which has not been curatively treated

- Inflammatory breast cancer without bi-dimensional measurable lesion

- Prior systemic therapy for cancer

- Previous therapy with trastuzumab or other anti-HER2 agent (for HER2+ tumors)

- Previous therapy with bevacizumab or other anti-VEGF agent

- Patients with immunosuppressive therapy

- Pregnant or lactating women

- Women of childbearing potential not using highly effective birth control.

- Patients with known hypersensitivity reactions to the compounds or incorporated
substances of trastuzumab or its constituents (for HER2+ tumors).

- Patients with known hypersensitivity reactions to the compounds or incorporated
substances of bevacizumab or its constituents.

- Invasive malignancy which could affect compliance with the protocol or interpretation
of results.

- Other serious illness or medical condition including:

- Known or suspected congestive heart failure (>NYHA I) and/or coronary heart

- Angina pectoris requiring antianginal medication

- Previous history of myocardial infarction

- Evidence of transmural infarction on ECG

- Un- or poorly controlled arterial hypertension (i.e. BP >150/100 mmHg under
treatment with two antihypertensive drugs)

- Rhythm abnormalities requiring permanent treatment

- Clinically significant valvular heart disease

- Patients with dyspnoea at rest due to malignant or other disease or who require
supportive oxygen therapy

- Active serious uncontrolled infections

- Poorly controlled diabetes

- History of hypertensive crisis or hypertensive encephalopathy

- History of TIA or CVA

- History of any arterial thrombotic event within 12 months before randomization

- Inadequate bone marrow, hepatic and renal functions as evidenced by the following:

- Neutrophil count of < 1500, platelet count of < 100,000/µL

- Haemoglobin < 10 g/dL

- Serum total bilirubin > ULN (except for patients with clearly documented Gilbert's

- ALT or AST > 1.5 x ULN

- Alkaline phosphatase > 2.5 x ULN, serum creatinine > ULN

- Concurrent treatment with any other anti-cancer therapy

- No informed consent for analysis of predictive imaging tests and biomarkers

- Contraindications against MRI: Cardiac pacemakers, other forms of medical or
biostimulation implants, ferromagnetic foreign bodies or metallic implants (e.g.
surgical protheses, aneurysm clips), implanted insulin pumps, valvular implants,
allergy to contrast agent, renal insufficiency, claustrophobia

- Active peptic ulcer, incomplete wound healing or unhealed bone fracture

- Previous thromboembolic events, known hemorrhagic diathesis, coagulopathy with
increased bleeding risk, or treatment with anticoagulants. Current or recent (within
10 days of first dose of bevacizumab) use of acetalic acid (> 325 mg/day) or
clopidogrel (> 75 mg/day)

- Disease significantly affecting gastrointestinal function, e.g. malabsorption
syndrome, resection of the stomach or small bowel, ulcerative colitis; abdominal
fistula, intra-abdominal abscess within 6 months of enrolment or gastrointestinal

- Major surgery within the last 28 days or anticipation of the need for major surgery
during study treatment with bevacizumab. No minor surgeries including insertion of an
indwelling catheter within 24h prior to registration.

- Concurrent treatment with other experimental drugs; participation in another clinical
trial with any investigational drug within 30 days prior to study entry

- Chronic daily treatment with corticosteroids (dose of > 10 mg/day methylprednisolone
equivalent) (excluding inhaled steroids).

- Patients with a history of hypersensitivity reaction to docetaxel or to drugs
formulated with polysorbate 80

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Rate of pathological complete response (pCR) following neoadjuvant therapy in group A and group B

Outcome Description:

To determine efficacy of cytotoxic-antiangiogenic neoadjuvant therapy in primary breast cancer: bevacizumab+trastuzumab+docetaxel fro group A (HER2 positive) or bevacizumab+docetaxel for group B (HER2 negative) using pathological complete response (pCR) as the primary endpoint.

Outcome Time Frame:

about 18 weeks (start of neoadjuvant chemotherapy until surgery)

Safety Issue:


Principal Investigator

Nadia Harbeck, Prof. Dr. med.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Head of Breast Centre, University of Munich, Grosshadern Hospital, Germany


Germany: Ethics Commission

Study ID:




Start Date:

September 2012

Completion Date:

September 2019

Related Keywords:

  • Primary Breast Cancer
  • Neoadjuvant chemotherapy
  • Neoadjuvant cytotoxic-antiangiogenic therapy
  • Bevacizumab
  • PET
  • Breast Neoplasms