Clinical trial · Interventional
Pegylated Liposomal Doxorubicin and Docetaxel in Treating Women With Locally Advanced Breast Cancer That Can Be Removed By Surgery
Phase II Study of Neoadjuvant Pegylated Liposomal Doxorubicin and Docetaxel in Locally Advanced Operable Breast Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Terminated by sponsor due to lack of funding
Summary
Brief summary (as posted)
RATIONALE: Drugs used in chemotherapy, such as liposomal doxorubicin and docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) and giving them before surgery may kill more tumor cells. PURPOSE: This phase II trial is studying the side effects of giving liposomal doxorubicin together with docetaxel before surgery and to see how well it works in treating women with locally advanced breast cancer that can be removed by surgery.
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 (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| conventional surgery | Procedure | — | UNRESOLVED |
| docetaxel | Drug | Docetaxel | ALIAS |
| neoadjuvant therapy | Procedure | — | UNRESOLVED |
| pegylated liposomal doxorubicin hydrochloride | Drug | Doxorubicin | ALIAS |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (2)
- measure
- Pathological Complete Response
- timeFrame
- Mammogram done pre-treatment and after four and six cycles of study chemotherapy treatment.
- measure
- Clinical Complete Response
- timeFrame
- Surgery done after completion of six cycles of study chemotherapy treatment.
Secondary outcomes (3)
- measure
- Overall Clinical Local Regional Response
- timeFrame
- Mammogram done pre-treatment and after four and six cycles of study chemotherapy treatment.
- measure
- Number of Women Who Would Have Required a Mastectomy Upfront But Who Underwent Breast Conservation Therapy Instead After Neoadjuvant Chemotherapy
- timeFrame
- Baseline (pre-treatment) surgical assessment, and post-chemotherapy surgical outcome.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Maximum age
- 64 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS:
* Histologically or cytologically confirmed breast cancer using core biopsies
* Locally advanced disease
* Resectable disease
* Fine needle aspiration cytology allowed and must demonstrate invasive adenocarcinoma
* No more than 8 weeks since initial cytologic or histologic diagnosis of breast cancer
* Tumor must meet the following criteria:
* Palpable on clinical examination and confined to either the breast or to the breast and ipsilateral axilla
* Measured clinically as greater than 2 cm in size (T2)
* Patients with skeletal pain are eligible if bone scan and/or roentgenological examination fail to disclose metastatic disease
* Suspicious findings must be confirmed as benign by x-ray, MRI scan, or biopsy
* Hormonal status not specified
PATIENT CHARACTERISTICS:
Inclusion criteria:
* Female
* Menopausal status not specified
* ECOG performance status 0-2
* Life expectancy ≥ 10 years
* Platelet count ≥ 100,000/mm³
* ANC ≥ 1,500/mm³
* Hemoglobin ≥ 9.0 g/dL
* Bilirubin normal
* AST or ALT normal
* Alkaline phosphatase normal
* Serum creatinine normal
* Negative pregnancy test
* Fertile patients must use effective contraception (e.g., abstinence, intrauterine device, barrier device with spermicide, or surgical sterilization) during and for 3 months after completion of study therapy
* Normal cardiac function by LVEF or MUGA scan
* Patients with prior non-breast malignancies are eligible if they have been disease-free for ≥ 10 years
* The following are allowed even if diagnosed within the past 10 years:
* Squamous or basal cell carcinoma of the skin that has been effectively treated
* Carcinoma in situ of the cervix that has been treated by operation only
* Lobular carcinoma in situ of the ipsilateral or contralateral breast treated by segmental resection only
Exclusion criteria:
* Pregnant or lactating women
* Male patients
* Hyperbilirubinemia
* Female patients with 1 or more of the following conditions:
* Ulceration, erythema, infiltration of the skin (complete fixation), or peau d'orange (edema) of any magnitude
* Tethering or dimpling of the skin or nipple inversion should not be interpreted as skin infiltration
* Ipsilateral lymph nodes that are clinically fixed to one another or to other structures (N2 disease)
* Bilateral malignancy or a mass in the opposite breast suspicious for malignancy, unless there is biopsy proof that the mass is not malignant
* Suspicious palpable nodes in the contralateral axilla or palpable supraclavicular or infraclavicular nodes, unless there is biopsy evidence that these are not involved with the tumor
* Nonmalignant systemic disease (e.g., cardiovascular, renal, or hepatic) that would preclude study therapy
* Active cardiac disease that would preclude the use of doxorubicin hydrochloride, including any of the following:
* Documented myocardial infarction
* Angina pectoris that requires the use of antianginal medication
* History of documented New York Heart Association class II-IV heart failure
* Valvular disease with documented cardiac function compromise
* Poorly controlled hypertension (i.e., diastolic BP \> 100 mm Hg)
* Patients with well-controlled hypertension and on medication are eligible for study
* Psychiatric or addictive disorders that would preclude obtaining informed consent
PRIOR CONCURRENT THERAPY:
Inclusion criteria:
* Concurrent noncancer therapies allowed if used for conditions other than breast cancer
* Adjuvant therapy after surgery allowed
Exclusion criteria:
* Prior radiotherapy, chemotherapy, immunotherapy, and/or hormonal therapy for breast cancer
* Prior anthracycline therapy for any condition
* Concurrent hormonal therapy including tamoxifen, aromatase inhibitors, or raloxifene
* Concurrent sex hormonal therapy including birth-control pills or ovarian hormonal replacement therapy
* Concurrent other cancer therapy
* Concurrent herbal or alternative therapies for breast cancerReferences
Publications (0)
Data not yet available