Clinical trial · Interventional
Monoclonal Antibody Therapy and Docetaxel in Treating Women With Metastatic or Recurrent Breast Cancer
A Phase II Study Using SGN-15 (cBR96 - Doxorubicin Immunoconjugate) in Combination With Taxotere for the Treatment of Metastatic or Recurrent Breast Carcinoma
- 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 use different ways to stop tumor cells from dividing so they stop growing or die. Monoclonal antibodies can locate tumor cells and deliver tumor-killing substances to them without harming normal cells. Combining chemotherapy with monoclonal antibody therapy may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of combining docetaxel and monoclonal antibody therapy in treating women who have metastatic or recurrent 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 (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| cBR96-doxorubicin immunoconjugate | Drug | — | UNRESOLVED |
| docetaxel | Drug | Docetaxel | ALIAS |
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS:
* Histologically confirmed metastatic or recurrent breast carcinoma
* Unresectable disease
* Previously treated with no more than 2 chemotherapy regimens for metastatic disease OR
* Recurrent within 6 months of adjuvant chemotherapy
* Must have one of the following:
* Measurable disease
* Positive bone scan and elevation of serum tumor marker for adenocarcinoma
* Serum levels must have increased over 2 consecutive measurements and exceed at least 2 times upper limit of normal
* Lewis-y antigen expression documented by immunohistochemistry
* No brain metastases that are uncontrolled or require active treatment (including steroids)
* Hormone receptor status:
* Not specified
PATIENT CHARACTERISTICS:
Age:
* 18 and over
Sex:
* Female
Menopausal status:
* Not specified
Performance status:
* ECOG 0-2
Life expectancy:
* At least 3 months
Hematopoietic:
* Hemoglobin at least 10 g/dL
* Absolute neutrophil count at least 1,500/mm\^3
* Platelet count at least 100,000/mm\^3
* No bleeding diathesis
Hepatic:
* Bilirubin no greater than 1.5 mg/dL
* SGOT no greater than 2.5 times normal
* Alkaline phosphatase no greater than 2.5 times normal (unless documented bony metastasis present)
* Amylase/lipase less than 1.5 times normal
* Hepatitis B and C negative
* No hepatic failure
Renal:
* Creatinine no greater than 1.5 times upper limit of normal
* No renal failure
Cardiovascular:
* LVEF greater than 50% by echocardiogram or MUGA scan
* No congestive heart failure
Other:
* HIV negative
* No antibody present that detects monoclonal antibody BR96 in serum
* No peripheral neuropathy grade 2 or greater
* No dementia or altered mental status
* No other serious underlying medical condition that would preclude study participation
* No prior allergic reactions to recombinant human or murine proteins
* No uncontrolled peptic ulcer disease
* No active viral, bacterial, or systemic fungal infections
* No other primary malignancy except nonmelanoma skin cancer or carcinoma in situ of the cervix
* No serious nonmalignant disease
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* At least 8 weeks since prior therapeutic or diagnostic murine/humanized/human chimeric antibodies
Chemotherapy:
* See Disease Characteristics
* At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas, carboplatin, mitomycin, or anthracyclines)
* No prior cumulative anthracycline of 300 mg/m2 or more
* No concurrent antineoplastic agents
Endocrine therapy:
* See Disease Characteristics
* At least 4 weeks since prior hormonal therapy
* No concurrent hormonal therapy except estrogen replacement
Radiotherapy:
* At least 4 weeks since prior radiotherapy
Surgery:
* See Disease Characteristics
Other:
* No other concurrent experimental agents
* No concurrent immunosuppressive medicationsReferences
Publications (0)
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