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Trial of Accelerated Adjuvant Chemotherapy With Capecitabine in Early Breast Cancer (TACT2)

Phase 3
18 Years
Open (Enrolling)
Breast Cancer

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Trial Information

Trial of Accelerated Adjuvant Chemotherapy With Capecitabine in Early Breast Cancer (TACT2)



- Compare the disease-free survival (DFS) of patients with completely resected early
stage breast cancer receiving 1 of 2 different schedules of adjuvant chemotherapy
comprising epirubicin, cyclophosphamide, methotrexate, and fluorouracil versus 1 of 2
different schedules of adjuvant chemotherapy comprising epirubicin and capecitabine.


- Compare overall survival (OS) and distant disease-free survival (DFS).

- Compare the tolerability (including serious adverse events [SAE], dose-intensity, and
toxicity) of these regimens.

- Determine the detailed toxicity of these regimens.

- Determine the quality of life of a subset of these patients.

OUTLINE: This is a multi-center, randomized study. Patients are stratified according to
participating center, nodal status (N0 vs N1-3 vs N≥ 4), age (≤ 50 years vs > 50 years), and
estrogen receptor (ER) status (negative vs positive). Patients are randomized to 1 of 4
treatment arms.

- Arm I: Patients receive epirubicin on day 1. Treatment repeats every 3 weeks for 4
courses. Patients then receive cyclophosphamide orally once daily on days 1-14 or IV on
days 1 and 8 and methotrexate and fluorouracil on days 1 and 8. Treatment repeats every
28 days for 4 courses.

- Arm II: Patients receive epirubicin on day 1 and pegfilgrastim on day 2. Treatment
repeats every 2 weeks for 4 courses. Patients then receive cyclophosphamide,
methotrexate and fluorouracil as in arm I.

- Arm III: Patients receive epirubicin as in arm I. Patients then receive oral
capecitabine twice daily on days 1-14. Treatment with capecitabine repeats every 3
weeks for 4 courses.

- Arm IV: Patients receive epirubicin and pegfilgrastim as in arm II. Patients then
receive capecitabine as in arm III.

In all arms, treatment continues in the absence of unacceptable toxicity.

Beginning 3-6 months later, all patients may undergo radiotherapy at the discretion of the
principal investigator. Patients with ER- and/or progesterone receptor-positive disease then
receive tamoxifen citrate or an aromatase inhibitor for up to 5 years.

Quality of life is assessed in a cohort of 1,000 patients in week 6, week 8 or 12, and week
20 or 24 during treatment and then at 12 and 24 months after randomization.

After completion of study therapy, patients are followed every 6 months for 2 years and then
annually for at least 10 years.

Peer Reviewed and Funded or Endorsed by Cancer Research UK.

PROJECTED ACCRUAL: A total of 4,400 patients will be accrued for this study.

Inclusion Criteria


- Histological diagnosis of invasive breast carcinoma

- Cytological proof of malignancy alone is not sufficient

- Early stage disease (T0-3, N0-2, M0) without clinical suspicion or evidence of
distant metastases on routine staging

- No locally advanced breast cancer (T4 and/or N3 disease)

- Completely resected disease by breast-conserving surgery with axillary node clearance
or modified radical mastectomy within the past 4-8 weeks

- Negative surgical margins required, unless either of the following are true:

- Deep surgical margins after full thickness resection

- Noninvasive cancer at surgical margins for which a mastectomy is planned
after completion of study chemotherapy

- No contraindication for or refusal of postoperative radiotherapy in patients who
underwent prior breast-conserving surgery

- Definite indication for adjuvant chemotherapy

- No prior or current invasive breast cancer or bilateral breast cancer

- Prior surgically-treated ductal carcinoma in situ or lobular carcinoma in situ

- Hormone receptor status:

- Estrogen receptor- and/or progesterone receptor-positive or -negative tumor


- Sex: male or female

- Menopausal status: premenopausal or postmenopausal

- No previous malignancy except basal cell carcinoma, carcinoma in situ of the cervix,
or any cancer from which the patient has been disease-free for 10 years and for which
treatment consisted solely of resection

- ECOG status 0 or 1

- Hemoglobin > 9 g/dL

- WBC > 3,000/mm³

- Platelet count > 10,000/mm³

- Bilirubin normal (unless due to known Gilbert's disease)

- AST and ALT ≤ 1.5 times upper limit of normal (ULN)

- Albumin normal

- Creatinine ≤ 1.5 times ULN

- Creatinine clearance > 50 mL/min

- No active, uncontrolled infection

- Not pregnant or nursing

- Fertile patients must use effective contraception

- No concurrent medical, psychiatric, or geographic problems that might prevent
completion of treatment or follow-up

- Available for a minimum of 5 years' follow-up

- No known serious viral infection such as active hepatitis B, hepatitis C, or HIV

- No significant cardiac disease, such as impaired left ventricular function or active
angina requiring regular anti-anginal medication and/or resulting in restricted
physical activity

- No history of significant renal impairment or disease


- No simultaneous participation in the active intervention phase of another treatment

- Not being approached or recruited for another trial within 2 months of study entry

- No previous chemotherapy, hormonal therapy or radiotherapy for the treatment of
pre-invasive or invasive cancer except for either of the following:

- Previous radiotherapy for basal cell carcinoma

- Previous preoperative endocrine therapy, provided there was no evidence of
progression during this therapy, it lasted for less than 6 weeks in duration,
and it was stopped at least one month prior to trial entry

- Concurrent luteinizing hormone-releasing hormone analog therapy allowed for
premenopausal patients

- More than 4 weeks since prior hormone replacement therapy (HRT) or pre-operative
endocrine therapy

- No prior breast conserving surgery if there is a contradiction for or refusal of
postoperative radiotherapy

Type of Study:


Study Design:

Allocation: Randomized, Primary Purpose: Treatment

Outcome Measure:

Disease-free survival (DFS) at 5 years

Safety Issue:


Principal Investigator

David Cameron, MD

Investigator Role:

Study Chair

Investigator Affiliation:

National Cancer Research Network


United States: Federal Government

Study ID:




Start Date:

December 2005

Completion Date:

Related Keywords:

  • Breast Cancer
  • stage I breast cancer
  • stage II breast cancer
  • stage IIIA breast cancer
  • male breast cancer
  • Breast Neoplasms