Phase III Randomized Study of Trastuzumab (Herceptin) With or Without Tamoxifen in Women With Progressive, Stage IV, Estrogen or Progesterone Receptor- and HER2/Neu-Positive Breast Cancer


Phase 3
18 Years
N/A
Not Enrolling
Both
Stage IV Breast Cancer, Recurrent Breast Cancer

Thank you

Trial Information

Phase III Randomized Study of Trastuzumab (Herceptin) With or Without Tamoxifen in Women With Progressive, Stage IV, Estrogen or Progesterone Receptor- and HER2/Neu-Positive Breast Cancer


OBJECTIVES:

- Compare time to progression in women with progressive, stage IV, estrogen or
progesterone receptor- and HER2/neu-positive breast cancer treated with trastuzumab
(Herceptin) with or without tamoxifen.

- Correlate response with type of measurement (immunohistochemistry or fluorescent in
situ hybridization) of HER2/neu expression in patients treated with these regimens.

- Compare objective response rate (complete or partial response) in patients treated with
these regimens.

OUTLINE: This is a randomized study. Patients are stratified according to prior adjuvant
treatment (yes vs no), ECOG performance status (0-1 vs 2), and prior aromatase inhibitor
treatment (yes vs no). Patients are randomized to 1 of 2 treatment arms.

- Arm I: Patients receive trastuzumab (Herceptin) IV over 60-90 minutes on day 1.

- Arm II: Patients receive trastuzumab as in arm I and oral tamoxifen once daily on days
1-21.

In both arms, treatment repeats every 3 weeks for at least 2 courses in the absence of
disease progression or unacceptable toxicity.

Patients are followed every 3 months for 5 years.

PROJECTED ACCRUAL: A total of 280 patients (140 per treatment arm) will be accrued for this
study within 28 months.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically confirmed invasive stage IV breast cancer

- Hormone receptor status:

- HER2/neu positive (3+ by immunohistochemical [IHC] assay or fluorescent in situ
hybridization [FISH])

- Estrogen receptor or progesterone receptor positive

- Measurable or evaluable disease

- Must have disease progression within 6 months of initiation of tamoxifen
(administered in the adjuvant or metastatic setting) or during aromatase inhibitor
therapy

PATIENT CHARACTERISTICS:

Age

- 18 and over

Sex

- Female

Menopausal status

- Not specified

Performance status

- ECOG 0-2

Life expectancy

- Not specified

Hematopoietic

- Absolute neutrophil count at least 1,000/mm^3

- Platelet count at least 75,000/mm^3

Hepatic

- Bilirubin no greater than 1.5 times upper limit of normal (ULN)

- SGOT and SGPT no greater than 2.5 times ULN

Renal

- Not specified

Cardiovascular

- LVEF normal by MUGA

Other

- Not pregnant or nursing

- Fertile patients must use effective nonhormonal contraception during and for at least
2 months after study completion

- No other concurrent active malignancy except nonmelanoma skin cancer

- Patients who have completed prior therapy and are at less than 30% risk of relapse
are not considered to have an active malignancy

PRIOR CONCURRENT THERAPY:

Biologic therapy

- No prior trastuzumab (Herceptin) in the adjuvant or metastatic setting

Chemotherapy

- No more than 1 prior chemotherapy regimen in the metastatic setting

- No concurrent chemotherapy

Endocrine therapy

- See Disease Characteristics

- No more than 1 prior hormonal therapy regimen for metastatic disease

- Prior aromatase inhibitor therapy administered in the first-line metastatic or
adjuvant setting is allowed provided there is disease progression on tamoxifen

- No other concurrent hormonal therapy except the following:

- Steroids for adrenal failure

- Hormones for nondisease-related conditions (e.g., insulin for diabetes)

- Intermittent use of dexamethasone as an antiemetic

- Vaginal estrogen (or Estring®) for vaginal dryness

Radiotherapy

- No concurrent palliative radiotherapy except whole brain irradiation for CNS disease

Surgery

- Not specified

Other

- Concurrent bisphosphonates allowed

- No concurrent cardioprotective drugs

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Joanne E. Mortimer, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Sentara Cancer Center

Authority:

United States: Federal Government

Study ID:

CDR0000269409

NCT ID:

NCT00053339

Start Date:

Completion Date:

Related Keywords:

  • Stage IV Breast Cancer
  • Recurrent Breast Cancer
  • Breast Neoplasms

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