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Phase II Trial of Herceptin Concurrent With External Beam Radiation Following Neoadjuvant Chemotherapy for the Treatment of HER2 Over-Expressing Breast Cancer

Phase 2
18 Years
Not Enrolling
Breast Cancer

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Trial Information

Phase II Trial of Herceptin Concurrent With External Beam Radiation Following Neoadjuvant Chemotherapy for the Treatment of HER2 Over-Expressing Breast Cancer



- Determine the tolerability of trastuzumab (Herceptin®) and concurrent external beam
radiotherapy in women with HER2-overexpressing stage III or IV breast cancer.


- Determine the pathologic response rate in patients treated with this regimen.

- Determine the locoregional recurrence rate (as site of first recurrence or any
recurrence) and time to locoregional recurrence in patients treated with this regimen.

- Determine the time to local progression in patients (who are deemed to be non-surgical
candidates) treated with this regimen .

OUTLINE: This is a multicenter study.

Patients receive trastuzumab IV over 30-90 minutes once a week for 5 weeks. Patients also
undergo external beam radiotherapy once daily 5 days a week for 5 weeks.

Three weeks after the completion of trastuzumab and radiotherapy, patients undergo surgical
evaluation. Patients deemed to be surgical candidates undergo surgery. Patients deemed to be
non-surgical candidates continue to receive trastuzumab and external beam radiotherapy for 2
additional weeks.

After completion of study therapy, patients are followed up every 3 months for 2 years and
then every 6 months for 3 years.

Inclusion Criteria


- Histologically confirmed* invasive primary carcinoma of the breast by fine-needle
aspiration, core needle biopsy, or incisional biopsy

- Excisional biopsy is not allowed

- Stage III or IV disease (clinical and radiographic staging), including any of the

- Any T with N2 disease (metastasis to ipsilateral axillary lymph nodes fixed to
one another or other structures) or N3 disease (metastasis to ipsilateral
internal mammary lymph nodes)

- T4, any N disease

- Inflammatory disease

- Supraclavicular and/or infraclavicular adenopathy

- Distant metastasis with measurable disease in the breast or lymph nodes

- HER2-overexpressing tumor

- Measurable or evaluable disease

- Residual locoregional disease after completion of neoadjuvant chemotherapy OR
locoregional recurrent disease

- Synchronous bilateral primary cancers allowed provided the more serious of the two
cancers meets staging criteria

- Hormone receptor status not specified


- Menopausal status not specified

- WBC > 2,000/mm^3

- Platelet count > 50,000/mm^3

- Hemoglobin > 11 g/dL

- Negative pregnancy test

- Fertile patients must use effective contraception

- Radionucleotide ventriculography/LVEF normal OR ≤ 10% asymptomatic decline from
baseline after completion of neoadjuvant chemotherapy


- See Disease Characteristics

- No prior radiotherapy to the breast or regional lymph nodes

- Concurrent participation in neoadjuvant chemotherapy clinical trials allowed

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:

Number of subjects experiencing adverse events

Outcome Description:

Toxicity (adverse events) will be measured and graded using the CTCAE criteria. RTOG acute toxicity criteria will be used to score acute radiation-related toxicity

Outcome Time Frame:

7 weeks

Safety Issue:


Principal Investigator

Carolyn Sartor, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

UNC Lineberger Comprehensive Cancer Center


United States: Federal Government

Study ID:

LCCC 9925



Start Date:

March 2000

Completion Date:

July 2009

Related Keywords:

  • Breast Cancer
  • HER2-positive breast cancer
  • inflammatory breast cancer
  • recurrent breast cancer
  • stage IIIA breast cancer
  • stage IIIB breast cancer
  • stage IIIC breast cancer
  • stage IV breast cancer
  • Breast Neoplasms