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TRastuzumab in HER2-negative Early Breast Cancer as Adjuvant Treatment for Circulating Tumor Cells (CTC) ("TREAT CTC" Trial)

Phase 2
18 Years
Open (Enrolling)
Breast Cancer, Human Epidermal Growth Factor 2 Negative Carcinoma of Breast, Circulating Tumor Cells

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Trial Information

TRastuzumab in HER2-negative Early Breast Cancer as Adjuvant Treatment for Circulating Tumor Cells (CTC) ("TREAT CTC" Trial)

This is a randomized phase II trial for patients with HER2 negative primary BC who after
completing (neo) adjuvant chemotherapy and surgery have detectable CTC(s) in peripheral
blood (see eligibility criteria for details). Eligible patients will be randomized in 1:1
ratio to either the trastuzumab arm or the observation arm. Patients randomized to the
trastuzumab arm will receive a total of 6 intravenous (IV) administrations every 3 weeks
(loading dose 8 mg/kg IV and 5 cycles at 6 mg/kg every 3 weeks). Patients randomized to
observation arm shall be observed for 18 weeks. Left ventricular ejection fraction (LVEF)
assessment (MUGA and/or ECHO) will be done at baseline for all patients to be randomized.
The next LVEF assessments of weeks 9 and week 18 will be done only in patients randomized to
trastuzumab arm. Patient registered but with CTC negative result will not be followed-up.

Inclusion Criteria:

- Female gender

- WHO performance status 0-1

- Non-metastatic and non-relapsed operable primary invasive HER2 negative
adeno-carcinoma of the breast that is adequately excised and all of the following:

- histological grade > 1 at the time of surgery (all patients) and primary tumor
size > 1 cm

- the patient should have completed either

- adjuvant chemotherapy for node-positive disease (pN ≥1, macrometastasis only) or

- neoadjuvant chemotherapy. In this case, no pathological complete response
(defined as any residual invasive disease in breast or lymph nodes) after
neoadjuvant chemotherapy is required.

- Availability of peripheral blood draw for CTC blood test

- Tumor block or unstained slides of primary tumor must be available prior to
randomization for centralized HER2 testing

- Prior chemotherapy with doxorubicin restricted to a total dose of 360 mg/m2 or with
epirubicin restricted to a total dose of 720 mg/m2 is allowed.

- Adjuvant hormonal therapy or adjuvant radiotherapy (if applicable) is allowed upon
physician's choice

- The interval between definitive surgery (neoadjuvant group) or end of adjuvant
chemotherapy (adjuvant group) and registration must be at least 3 weeks but no more
than 12 weeks.

Exclusion Criteria:

- No further adjuvant chemotherapy treatment planned.

- No prior use of anti-HER2 therapy for any reason or other prior use of biological
agent or immunotherapy for BC

- No prior and/or concomitant use of bisphosphonate therapy for any reason is allowed.

- No prior mediastinal irradiation except internal mammary node irradiation for the
present BC

- No history of prior (ipsilateral and/or contralateral) invasive breast carcinoma or
ductal carcinoma in situ.

- No history of any malignant neoplasms in the past 5 years except for curatively
treated basal and squamous cell carcinoma of the skin.

- No history of serious cardiac illness or other concurrent serious diseases that may
interfere with planned treatment, including severe pulmonary conditions. Baseline
LVEF≥55% measured by echocardiography or MUGA scan (performed 2 weeks before

Eligibility Criteria at patient randomisation:

- ≥1CTC/15mL of blood by CellSearch® between 3 weeks and up to 12 weeks after surgery
(neoadjuvant population) or end of adjuvant chemotherapy (adjuvant population).

- Centrally confirmed HER2-negative primary BC. Centralized HER2 testing will be
performed in the surgical tumor specimen. A HER2-negative primary BC sample eligible
for randomization should have HER2 IHC scores of 0 or 1+ or 2+ AND should be HER2
FISH negative in central testing.

- Baseline LVEF≥55% measured by echocardiography or MUGA scan (performed within 2 weeks
prior to randomization)

- No evidence of unresolved or unstable serious toxicity from prior surgery, adjuvant
chemotherapy or radiotherapy

- No concurrent participation in another trial.

- Written informed consent must be given according to ICH/GCP, and national/local

Type of Study:


Study Design:

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

Outcome Measure:

CTC detection

Outcome Description:

To compare circulating tumour cell (CTC)detection rate at week 18 between trastuzumab treatment arm and observational arm.

Outcome Time Frame:

18 weeks post randomisation

Safety Issue:


Principal Investigator

Michail Ignatiadis, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Institut Jules Bordet, Brussels, Belgium


France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Study ID:




Start Date:

April 2013

Completion Date:

July 2016

Related Keywords:

  • Breast Cancer
  • Human Epidermal Growth Factor 2 Negative Carcinoma of Breast
  • Circulating Tumor Cells
  • Circulating Tumour Cells
  • HER2 negative primary breast cancer
  • HER2 positive CTC
  • Trastuzumab
  • Breast Neoplasms
  • Carcinoma
  • Neoplastic Cells, Circulating