Know Cancer

forgot password

Adjuvant Cytotoxic Chemotherapy In Older Women

Phase 3
70 Years
Open (Enrolling)
Breast Cancer

Thank you

Trial Information

Adjuvant Cytotoxic Chemotherapy In Older Women


- To provide evidence for extending the current standard care in older women with
invasive breast carcinoma treated with adjuvant chemotherapy comprising doxorubicin
hydrochloride or epirubicin hydrochloride and cyclophosphamide.

- Compare the relapse-free survival interval of these patients treated with adjuvant
chemotherapy vs no adjuvant chemotherapy.

- Compare the toxicity of accelerated adjuvant chemotherapy with pegfilgrastim support vs
non-accelerated adjuvant chemotherapy.

OUTLINE: This is a multicenter study. Patients are stratified according to participating
center and indication for endocrine therapy (yes vs no). Patients are randomized to 1 of 2

- Arm I (observation): Patients do not receive adjuvant chemotherapy.

- Arm II (adjuvant chemotherapy): Patients are randomized to 1 of 2 chemotherapy

- Accelerated adjuvant chemotherapy: Patients receive doxorubicin hydrochloride and
cyclophosphamide (AC) OR epirubicin hydrochloride and cyclophosphamide (EC) on day
1 and pegfilgrastim on day 2. Treatment repeats every 2 weeks for 4 courses in the
absence of disease progression or unacceptable toxicity.

- Non-accelerated adjuvant chemotherapy: Patients receive AC or EC on day 1.
Treatment repeats every 3 weeks for 4 courses in the absence of disease
progression or unacceptable toxicity.

Patients undergo tumor tissue and blood sample collection for biological, pharmacological,
and proteomic studies. Samples are initially used to establish a resource of materials
available for different research groups. Samples are also analyzed using SELDI or MALDI-ToF
technology to identify biological profiles that correlate with prognosis or predict response
to treatment.

Quality of life is assessed at baseline, 6 weeks, 1 month, 6 months, 9 months, 12 months, 18
months, and 24 months.

After completion of study treatment, patients are followed every 6 months for 2 years and
then annually thereafter.

Inclusion Criteria


- Histologically confirmed invasive breast carcinoma

- Primary operable breast cancer that was surgically treated by wide local excision or
mastectomy with clear margins (> 1 mm apart from deep margin if full thickness

- No more than 8 weeks since prior definitive surgery

- Early-stage disease with no evidence of metastases clinically or on routine staging

- No T4 and/or N3 disease

- Prior axillary staging required, including 1 of the following:

- Sentinel node biopsy

- Axillary sampling or clearance

- All node-positive patients must have had axillary clearance or radiotherapy
to the axilla

- Must be at high risk of relapse within 5 years (risk factors evaluated at clinician's

- No other invasive breast cancer, systemically treated ductal carcinoma in situ
(DCIS), or solid tumor within the past 5 years

- No prior hematologic malignancy or melanoma

- Hormone receptor status:

- Estrogen receptor (ER)- or progesterone receptor (PR)-negative OR ER/PR-weakly
positive (e.g., Allred/Quick score ≤ 5 OR H score ≤ 100)


- Female

- Postmenopausal

- Performance status 0-1

- Hemoglobin > 9 g/dL

- WBC > 3,000/mm³

- Platelet count > 100,000/mm³

- Bilirubin normal (unless known Gilbert's disease is present)

- Albumin normal

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

- Creatinine ≤ 1.5 x ULN

- Creatinine clearance > 50 mL/min

- No active or uncontrolled infection

- Must be available for routine long-term hospital follow-up

- Must have normal cardiac function and no significant cardiac disease by ECHO or MUGA


- See Disease Characteristics

- At least 4 weeks since prior preoperative endocrine therapy

- No prior systemic therapy for this breast cancer or mantle radiotherapy

- No prior breast-conserving surgery in which there is a contraindication for, or
decline of postoperative radiotherapy

- No concurrent hormone replacement therapy (HRT)

Type of Study:


Study Design:

Allocation: Randomized, Primary Purpose: Treatment

Outcome Measure:

Relapse-free interval

Safety Issue:


Principal Investigator

Robert C.F. Leonard, MD, BS, MB

Investigator Role:

Principal Investigator

Investigator Affiliation:

Charing Cross Hospital



Study ID:




Start Date:

January 2007

Completion Date:

Related Keywords:

  • Breast Cancer
  • stage IA breast cancer
  • stage IB breast cancer
  • stage II breast cancer
  • stage IIIA breast cancer
  • Breast Neoplasms