Clinical trial · Interventional
Liposomal Doxorubicin Before Mastectomy in Treating Women With Invasive Breast Cancer
A Phase I Study Assessing the Feasibility and Safety of Intraductal Administration of Pegylated Liposomal Doxorubicin (Doxil) in Women With Breast Cancer
- 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 liposomal doxorubicin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving chemotherapy in different ways, such as into the breast ducts, may kill more tumor cells. Giving chemotherapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. PURPOSE: This phase I trial is studying the side effects and best dose of liposomal doxorubicin when given before mastectomy in treating women with invasive 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 |
|---|---|---|---|
| Intraductal arm | Drug | — | UNRESOLVED |
| Intravenous arm | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Intraductal arm
- description
- Participants received intraductal administration of dextrose or dextrose with pegylated liposomal doxorubicin hydrochloride (or PLD) prior to conventional surgery for breast cancer.
- interventionNames
- Drug: Intraductal arm
- type
- ACTIVE_COMPARATOR
- label
- Intravenous arm
- description
- Participants receiving standard intravenous administration of pegylated liposomal doxorubicin prior to breast biopsy for drug concentrations.
- interventionNames
- Drug: Intravenous arm
Primary outcomes (1)
- measure
- Maximum Tolerated Dose (MTD)
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS:
* Histologically confirmed infiltrating carcinoma of the breast meeting any of the following criteria:
* T1-3, any N disease
* Proven ductal carcinoma in situ
* Unresected disease
* Planned mastectomy as definitive surgical procedure
* Known or suspected metastatic disease allowed provided mastectomy is planned
* Nonpalpable tumor allowed (e.g., initial T2-3 tumor that responded to preoperative therapy)
* No inflammatory breast cancer or other T4 features
* Successful baseline ductogram
* Baseline nipple aspiration procedure must identify a duct productive of nipple aspirate fluid
* No severe nipple retraction
* Hormone receptor status not specified
PATIENT CHARACTERISTICS:
* Female patients
* Menopausal status not specified
* ECOG performance status 0-2
* Absolute neutrophil count ≥1,500/mm\^3
* Platelet count ≥ 100,000/mm\^3
* Hemoglobin ≥ 9.0 g/dL
* Creatinine ≤ 2 times upper limit of normal (ULN)
* Bilirubin ≤ 2 times ULN
* AST and ALT ≤ 2.5 times ULN
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* No significant history of severe allergy to iodinated contrast material or debilitating anxiety that may not allow for a ductogram
PRIOR CONCURRENT THERAPY:
* See Disease Characteristics
* Prior preoperative chemotherapy, trastuzumab (Herceptin®), or hormonal therapy allowed provided it was completed 7-14 days prior to study treatment
* No prior radiation therapy, excisional biopsy, breast reduction, areolar surgery, or breast implant (present or past history of implant that was removed)
* No other prior procedure that may have altered the breast ductal system in the ipsilateral breast
* No other concurrent chemotherapy, radiotherapy, endocrine therapy, or biologic agents for breast cancer
* No other concurrent investigational drugs
* Concurrent bisphosphonates allowedReferences
Publications (1)
- RESULTStearns V, Mori T, Jacobs LK, Khouri NF, Gabrielson E, Yoshida T, Kominsky SL, Huso DL, Jeter S, Powers P, Tarpinian K, Brown RJ, Lange JR, Rudek MA, Zhang Z, Tsangaris TN, Sukumar S. Preclinical and clinical evaluation of intraductally administered agents in early breast cancer. Sci Transl Med. 2011 Oct 26;3(106):106ra108. doi: 10.1126/scitranslmed.3002368. PMID 22030751