Clinical trial · Interventional
Doxorubicin and Cyclophosphamide in Treating Older Women With Stage I, Stage II, or Stage III Breast Cancer That Has Been Removed By Surgery
Multicenter Pilot Clinical Study of Adjuvant Chemotherapy for Subjects Over 70 Years: Impact on the Independence and Quality of Life of the Administration of Anthracycline-Based Chemotherapy in Adjuvant Setting for Patients Presenting With Immediately Operable Breast Cancer, Hormone Receptor Negative (RH-), and Lymph Node Positive (pN+) or pN0 But of Scarff-Bloom-Richardson* Grade III and ≥ 2cm [GERICO]
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
RATIONALE: Drugs used in chemotherapy, such as doxorubicin and cyclophosphamide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving combination chemotherapy after surgery may kill any tumor cells that remain after surgery. PURPOSE: This phase II trial is studying how well giving doxorubicin together with cyclophosphamide works in treating older women with stage I , stage II, or stage III breast cancer that has been removed by surgery.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Cognitive/Functional Effects | — | UNRESOLVED | — |
| Depression | — | UNRESOLVED | — |
| Malnutrition | — | UNRESOLVED | — |
| Psychosocial Effects of Cancer and Its Treatment | — | UNRESOLVED | — |
Interventions
Interventions (8)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| AC regimen | Drug | — | UNRESOLVED |
| adjuvant therapy | Procedure | — | UNRESOLVED |
| cognitive assessment | Procedure | — | UNRESOLVED |
| cyclophosphamide | Drug | Cyclophosphamide | ALIAS |
| doxorubicin hydrochloride | Drug | Doxorubicin | ALIAS |
| management of therapy complications | Procedure | — | UNRESOLVED |
| psychosocial assessment and care | Procedure | — | UNRESOLVED |
| quality-of-life assessment | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Myocet, Endoxan
- interventionNames
- Drug: AC regimen
- Drug: cyclophosphamide
- Drug: doxorubicin hydrochloride
- Procedure: adjuvant therapy
- Procedure: cognitive assessment
- Procedure: management of therapy complications
- Procedure: psychosocial assessment and care
- Procedure: quality-of-life assessment
Primary outcomes (1)
- measure
- Percentage of patients maintaining their independence as assessed by Activities of Daily Living (ADL) score on 6 items after the fourth course of chemotherapy
- timeFrame
- 12 weeks
Secondary outcomes (1)
- measure
- Impact of adjuvant chemotherapy on ADL score, quality of life, treatment acceptability, toxicity, and survival (recurrence-free, progression-free, and overall survival)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 70 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS:
* Histologically confirmed invasive adenocarcinoma of the breast
* Stage I, II or III disease
* pN+ or pN0 with grade III disease (tumor size ≥ 2 cm)
* No metastatic disease
* Must have undergone prior conservative or radical surgery that included axillary lymph node or sentinel node dissection
* No residual tumor
* Negative margins
* Hormone receptor status:
* Estrogen receptor and progesterone receptor negative
PATIENT CHARACTERISTICS:
* Female
* Postmenopausal
* Absolute neutrophil count \> 1,500/mm³
* Platelet count \> 100,000/mm³
* Hemoglobin \> 10 g/dL
* Alkaline phosphatase \< 2.5 times upper limit of normal (ULN)
* Bilirubin \< 1.25 times ULN
* AST and ALT \< 2.5 times ULN
* Creatinine clearance ≥ 40 mL/min
* No contraindication to receiving anthracyclines or alkalizing agents
* FEV normal
* Activities of Daily Living (ADL) score ≥ 5
* No decrease of ≥ 1 point within the past 3 months
* None of the following at baseline:
* Cognitive deficiency (Folstein Mini-Mental State \< 25)
* Severe depression (Geriatric Depression Scale ≥ 20)
* Severe malnutrition (Mini-Nutritional Assessment ≤ 17)
* No other serious comorbid condition (Cumulative Illness Rating Scale - Geriatrics grade 3-4), including any of the following:
* Cardiac insufficiency
* Unstable angina
* Myocardiopathy
* Myocardial infarction within the past year
* Uncontrolled hypertension
* Uncontrolled high-risk arrhythmia
* Severe medullary insufficiency
* Neurological or psychological condition that would preclude study consent
* Uncontrolled or active infection
* Severe urinary tract infection
* Preexisting hematuria
* Active ulcer
* Uncontrolled diabetes
* No other cancer within the past 5 years except for basal cell skin cancer or carcinoma in situ of the cervix
* No familial, geographical, social, or psychological condition that would preclude study participation
PRIOR CONCURRENT THERAPY:
* See Disease Characteristics
* At least 60 days since prior therapeutic surgery
* At least 4 weeks since prior investigational drugsReferences
Publications (0)
Data not yet available