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Persephone: Duration of Trastuzumab With Chemotherapy in Women With Early Stage Breast Cancer: Six Months Versus Twelve


Phase 3
18 Years
N/A
Open (Enrolling)
Female
Breast Cancer

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Trial Information

Persephone: Duration of Trastuzumab With Chemotherapy in Women With Early Stage Breast Cancer: Six Months Versus Twelve


OBJECTIVES:

Primary

- Determine disease-free survival of women with HER2-positive early breast cancer treated
with neoadjuvant or adjuvant trastuzumab (Herceptin®) for 6 months versus 12 months.

Secondary

- Determine the overall survival of patients treated with these regimens.

- Determine the expected incremental cost effectiveness (cost per quality adjusted life
year gained) for 6 months versus 12 months trastuzumab.

- Determine cardiac function as assessed by left ventricular ejection fraction every 3
months during treatment.

- Analyze the predictive factors for development of cardiac damage.

OUTLINE: This is a multicenter study. Patients are stratified according to estrogen receptor
status (negative vs positive); chemotherapy timing (adjuvant vs neoadjuvant); chemotherapy
type (anthracycline based [no taxane] vs taxane and anthracyclines vs taxane-based [no
anthracyclines]); and trastuzumab (Herceptin®) timing (concurrently vs sequentially [with
respect to chemotherapy]). Patients are randomized to 1 of 2 treatment arms.

- Arm I: Patients receive trastuzumab IV over 30-90 minutes on day 1. Treatment repeats
every 3 weeks for up to 12 months in the absence of disease progression or unacceptable
toxicity.

- Arm II: Patients receive trastuzumab IV over 30-90 minutes on day 1. Treatment repeats
every 3 weeks for up to 6 months in the absence of disease progression or unacceptable
toxicity.

All patients also receive standard chemotherapy regimens as per local institutional
protocols either concurrently with or sequentially to trastuzumab.

Patients complete quality of life questionnaires using the EuroQoL-5D (EQ-5D) at baseline
and periodically during study treatment. Patients also complete a diary on out-of-pocket
expenses associated with their condition (i.e., travel expenses, over-the-counter medicines
and supplements, complementary therapies not funded by NHS, home help, and time away from
work) for cost-effective analysis.

After completion of study therapy, patients are followed every 3 months for 1 year, then
every 6 months for 1 year, and annually thereafter.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically confirmed invasive breast cancer

- No evidence of metastatic disease

- Overexpression of HER2 receptor defined as 3+ or 2+ HER2 positivity measured by
fluorescent in situ hybridization (FISH) gene amplification

- Indication for chemotherapy based on the following clinical and histopathological
features:

- Receiving or scheduled to receive neoadjuvant chemotherapy

- Time between diagnosis biopsy and start date of chemotherapy should be less
than 1 month

- Receiving or scheduled to receive adjuvant chemotherapy

- Completely resected disease, with negative surgical margins (apart from
deep margin if full thickness resection)

- Marginally resected disease and/or positive sentinel nodes allowed provided
patients undergo completion of surgery (breast and/or axillary clearance)
after chemotherapy

- Hormone receptor status known

PATIENT CHARACTERISTICS:

- Menopausal status not specified

- ECOG performance status 0-1

- Adequate bone marrow, hepatic, and renal function

- LVEF normal by ECHO or MUGA

- Not pregnant or nursing

- Fertile patients must use effective contraception

- No clinically significant cardiac abnormalities

- No myocardial infarction within the past 6 months

- No uncontrolled or malignant hypertension

- No history of atrioventricular arrhythmia and/or congestive heart failure (even under
medical control), or active second or third degree cardiac block

- No history of allergy to drugs containing polysorbate 20 and the excipient
polysorbate 80 (TWEEN 80®) or history of allergy to mouse proteins

- No co-morbidity significantly adding to risks associated with cytotoxic chemotherapy
(i.e., severe chronic obstructive pulmonary disease or poorly controlled diabetes)

- No prior diagnosis of malignancy unless managed by surgical treatment only and
disease-free for 10 years

- Prior basal cell carcinoma, cervical carcinoma in situ, or ductal carcinoma in
situ of the breast allowed if treated by surgery only

- No concomitant medical or psychiatric problems that might preclude completion of
treatment or follow-up

PRIOR CONCURRENT THERAPY:

- See Disease Characteristics

- No prior chemotherapy or radiotherapy

- Concurrent radiotherapy allowed

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Primary Purpose: Treatment

Outcome Measure:

Disease-free survival

Safety Issue:

No

Principal Investigator

Helena Earl, MBBS, PhD, FRCP

Investigator Role:

Principal Investigator

Investigator Affiliation:

Cambridge University Hospitals NHS Foundation Trust

Authority:

Unspecified

Study ID:

CDR0000598391

NCT ID:

NCT00712140

Start Date:

October 2007

Completion Date:

Related Keywords:

  • Breast Cancer
  • stage IA breast cancer
  • stage IB breast cancer
  • stage II breast cancer
  • stage IIIA breast cancer
  • HER2-positive breast cancer
  • Breast Neoplasms

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