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A Prospective Randomized Feasibility and Phase II Adjuvant Breast Cancer Study of the Netherlands Working Party for Autotransplantation in Solid Tumors.

Phase 2
18 Years
50 Years
Not Enrolling
High-Risk Breast Cancer

Thank you

Trial Information

A Prospective Randomized Feasibility and Phase II Adjuvant Breast Cancer Study of the Netherlands Working Party for Autotransplantation in Solid Tumors.

High-dose chemotherapy with the alkylating agent combination CTC appears to add
significantly to the efficacy of conventional dose chemotherapy in patients with high-risk
breast cancer, provided that the HER-2/neu gene is not amplified in the tumor. As a
high-dose chemotherapy regimen, CTC is associated with significant toxicity [31,32].
Although high-dose alkylating therapy seems to be effective, there is virtually nothing
known about the dose-response curve for this combination (for a detailed discussion see the
classical paper by E. Frei III [32]. If one assumes that the efficacy increase levels off
with increasing dose, the efficacy of tCTC might be almost as great as that of CTC, but with
considerably less toxicity. In addition, two closely spaced courses of tCTC might further
increase the efficacy of the regimen. There are some suggestions that a double transplant
may be more effective than a single one, in multiple myeloma and in Ewing sarcoma. A similar
suggestion has also been made for breast cancer (study of Nitz et al ref 4, table 1).

Inclusion Criteria

Inclusion criteria:

1. Modified radical mastectomy (or breast conserving surgery) and axillary clearance,
histologically confirmed stage IIA, IIB or IIIA adenocarcinoma (excluding
supraclavicular lymph nodes) of the breast, with 4 or more involved axillary lymph
nodes. Presence of tumor cells near or in the resection margins at microscopic
examination is acceptable

2. The primary tumor must be immunohistochemically negative for HER-2/neu expression. An
immunohistochemistry score of 1+ is also acceptable. A score of 3+ is not acceptable.
A score of 2+ is only acceptable if a FISH analysis (or equivalent) has clearly shown
that there is no HER-2/neu gene-amplification

3. No prior chemotherapy or radiotherapy

4. No evidence of distant metastases

5. Age < 50 years

6. Performance status (ECOG-ZUBROD) 0 or 1;

7. Normal bone marrow function, WBC > 4.0 x 109/l, platelets > 100 x 109/l;

8. Adequate renal function (creatinine clearance > 60 ml/min.);

9. Adequate hepatic function (serum bilirubin < 25 umol/l);

10. Study treatment must begin within 6 weeks of surgery;

11. No other malignancy except adequately treated in situ carcinoma of the cervix or
basal cell carcinoma of the skin;

12. No significant prior or concomitant disorder that might interfere with adherence to
the intensive treatment regimen, including but not limited to a history of angina,
myocardial infarction or heart failure, severe lung function impairment, peptic ulcer
disease, etc.;

13. Availability for follow-up.

Type of Study:


Study Design:

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

Outcome Measure:

Maximum degree of non-hematological toxicity.

Principal Investigator

Elisabeth G.E. de Vries, MD, PhD

Investigator Role:

Study Director

Investigator Affiliation:

University Medical Centre Groningen


Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Study ID:

METc 2004/110



Start Date:

October 2004

Completion Date:

Related Keywords:

  • High-Risk Breast Cancer
  • high dose
  • breast cancer
  • adjuvant
  • Breast Neoplasms