Clinical trial · Interventional
Combination Chemotherapy Plus Biological Therapy in Treating Patients With Stage II or Stage III Breast Cancer
Combination of Chemotherapy With Taxol, Adriamycin, and Cytoxan (TAC), Multiple Infusions of Activated T Cells (ATC), Interleukin-2 (IL-2) and GM-CSF for High Risk Breast Cancer With and Without Her2/Neu Overexpression. (Phase I/II)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): PI left Institution
Summary
Brief summary (as posted)
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Biological therapies use different ways to stimulate the immune system and stop tumor cells from growing. Combining chemotherapy with biological therapy may kill more tumor cells. PURPOSE: This phase I/II trial is studying the side effects of giving chemotherapy together with biological therapy and to see how well they work in treating patients with stage II or stage III breast cancer.
Conditions
Conditions (1)
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 |
Interventions
Interventions (7)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| aldesleukin | Biological | Aldesleukin | ALIAS |
| cyclophosphamide | Drug | Cyclophosphamide | ALIAS |
| doxorubicin hydrochloride | Drug | Doxorubicin | ALIAS |
| filgrastim | Biological | Filgrastim | ALIAS |
| paclitaxel | Drug | Paclitaxel | ALIAS |
| sargramostim | Biological | — | UNRESOLVED |
| therapeutic autologous lymphocytes | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (4)
- measure
- Toxicity
- measure
- Disease-free survival
- measure
- Overall survival
- measure
- Immune functions
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS:
* Histologically confirmed stage II or III adenocarcinoma of the breast
* High-risk disease
* At least 4 positive lymph nodes
* Fewer than 4 positive lymph nodes considered high-risk if one of the following is present:
* HER2/neu-positive disease
* Enlarged axillary nodes
* Extra capsular extension of tumor from lymph node
* Dermal lymphatic invasion
* Vascular invasion
* Bilateral disease
* Familial breast cancer
* T4 locally advanced disease
* Clinically chemosensitive to prior paclitaxel (or other taxane), doxorubicin, and cyclophosphamide
* No relapse after chemotherapy
* No clinical evidence of brain metastases
* Hormone receptor status:
* Estrogen and progesterone receptor status known
PATIENT CHARACTERISTICS:
Age:
* 18 and over
Sex:
* Female
Menopausal status:
* Not specified
Performance status:
* Karnofsky 70-100% OR
* ECOG 0-2
Life expectancy:
* At least 3 months
Hematopoietic:
* Granulocyte count at least 1,500/mm\^3
* Platelet count at least 50,000/mm\^3
* Hemoglobin greater than 8 g/dL
Hepatic:
* Bilirubin less than 1.5 times normal
* SGOT less than 1.5 times normal
Renal
* Creatinine less than 1.8 mg/dL
* Creatinine clearance at least 60 mL/min
* BUN less than 1.5 times normal
Cardiovascular:
* Ejection fraction at least 45% by MUGA
* No uncontrolled or significant cardiovascular disease
* No myocardial infarction within the past year
* No significant congestive heart failure
Pulmonary:
* FEV\_1 at least 60% predicted
* DLCO at least 60% predicted
* FVC at least 60% predicted
Other:
* No other malignancy except curatively treated squamous cell carcinoma in situ of the cervix or basal cell skin cancer
* No other serious medical or psychiatric illness that would preclude study participation
* HIV negative
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* Not specified
Chemotherapy:
* See Disease Characteristics
* Prior standard chemotherapy with anthracyclines or combination chemotherapy involving a combination of taxanes, doxorubicin, and/or cyclophosphamide allowed
Endocrine therapy:
* No concurrent hormonal therapy for breast cancer
* Concurrent hormonal therapy for nondisease-related conditions (e.g., insulin for diabetes) allowed
* Concurrent steroids for adrenal failure, septic shock, or pulmonary toxicity allowed
Radiotherapy:
* Not specified
Surgery:
* Prior complete resection of tumor allowed
Other:
* Prior successful neoadjuvant therapy allowedReferences
Publications (0)
Data not yet available