Breast Cancer Clinical Trial
Official title:
Phase II Clinical Trial of Neoadjuvant Weekly Doxorubicin, Polyglutamate Paclitaxel, Capecitabine and Metronomic Chemotherapy in Breast Cancer
Verified date | April 2017 |
Source | University of Southern California |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The investigators propose to conduct a clinical trial of neoadjuvant treatment utilizing
chemotherapy formulations with favorable toxicity profiles: weekly doxorubicin, PPX and
capecitabine. It is expected this combination will at least maintain the efficacy of a
traditional chemotherapy regimen but will be associated with less toxicity, particularly
nausea, vomiting and alopecia. In order to accomplish this the investigators have designed a
chemotherapy regimen whose components (or administration schedule) are associated with
minimal or no alopecia and are also considered to have low emetogenic potential.
In an attempt to improve the efficacy of the regimen the investigators plan to study an
alternate schedule of cyclophosphamide and methotrexate administration (metronomic
chemotherapy) which appears to inhibit angiogenesis and therefore enhance the activity of
conventional cytotoxic chemotherapy administered concurrently.
In this trial the investigators aim to determine the clinical and pathologic response rate
of 12 weeks of doxorubicin followed by 4 cycles of PPX and capecitabine. Metronomic
chemotherapy with cyclophosphamide and methotrexate will be administered during the 24 weeks
of chemotherapy.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | February 2011 |
Est. primary completion date | February 2010 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - SWOG performance status of 0-2 - Projected life expectancy of at least 3 months - Female age 18 years and over - Provision of informed consent prior to any study-related procedures. - Hormone receptor positive or negative tumor - Her 2 neu negative tumor - Negative pregnancy test for women of childbearing potential - Patients must agree to use some form of contraception while on this study at initiation and for the duration of participation in the study. Sexually active males must also use a reliable and appropriate method of contraception. Post-menopausal women must be amenorrheic for at least 12 months to be considered of non-childbearing potential. - ANC > 1500, Platelet count > 100,000, Hemoglobin > 9.0 - Serum creatinine < 1.5 mg/dl - Hepatic function: Patients must have adequate liver functions: AST or ALT < 2.5 X upper limit of normal (ULN), alkaline phosphatase < 2.5 X upper limit of normal. Serum Bilirubin < 1.5 mg - Peripheral neuropathy grade 0-1 - No other concomitant therapy directed at the cancer is allowed. Exclusion Criteria: - Serum bilirubin > 1.5 the upper limit of reference range (ULRR) - Serum creatinine >1.5 - Prior therapy for this tumor. - Clinical Congestive Heart Failure - Women who are currently pregnant or breast feeding. - Receipt of any investigational agents within 30 days prior to commencing study treatment - Prior radiation must not have included = 30% of major bone marrow containing areas (pelvis, lumbar spine) - No other prior malignancy is allowed except for the following: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, lobular carcinoma in-situ of the breast (LCIS), or any other cancer from which the patient has been disease-free for 5 years. Patients with prior invasive breast cancer or ductal carcinoma in-situ (DCIS) are eligible if they have been disease free for 5 years and did not receive prior treatment with doxorubicin and/or a taxane. |
Country | Name | City | State |
---|---|---|---|
United States | USC/Norris Comprehensive Cancer Center | Los Angeles | California |
Lead Sponsor | Collaborator |
---|---|
University of Southern California | CTI BioPharma |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Response | At surgical resection on about week 30 | ||
Secondary | Toxicity | Every 4 weeks |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT04681911 -
Inetetamab Combined With Pyrotinib and Chemotherapy in the Treatment of HER2 Positive Metastatic Breast Cancer
|
Phase 2 | |
Completed |
NCT04890327 -
Web-based Family History Tool
|
N/A | |
Terminated |
NCT04066790 -
Pyrotinib or Trastuzumab Plus Nab-paclitaxel as Neoadjuvant Therapy in HER2-positive Breast Cancer
|
Phase 2 | |
Completed |
NCT03591848 -
Pilot Study of a Web-based Decision Aid for Young Women With Breast Cancer, During the Proposal for Preservation of Fertility
|
N/A | |
Recruiting |
NCT03954197 -
Evaluation of Priming Before in Vitro Maturation for Fertility Preservation in Breast Cancer Patients
|
N/A | |
Terminated |
NCT02202746 -
A Study to Assess the Safety and Efficacy of the VEGFR-FGFR-PDGFR Inhibitor, Lucitanib, Given to Patients With Metastatic Breast Cancer
|
Phase 2 | |
Active, not recruiting |
NCT01472094 -
The Hurria Older PatiEnts (HOPE) With Breast Cancer Study
|
||
Completed |
NCT06049446 -
Combining CEM and Magnetic Seed Localization of Non-Palpable Breast Tumors
|
||
Withdrawn |
NCT06057636 -
Hypnosis for Pain in Black Women With Advanced Breast Cancer: A Feasibility Study
|
N/A | |
Recruiting |
NCT05560334 -
A Single-Arm, Open, Exploratory Clinical Study of Pemigatinib in the Treatment of HER2-negative Advanced Breast Cancer Patients With FGFR Alterations
|
Phase 2 | |
Active, not recruiting |
NCT05501769 -
ARV-471 in Combination With Everolimus for the Treatment of Advanced or Metastatic ER+, HER2- Breast Cancer
|
Phase 1 | |
Recruiting |
NCT04631835 -
Phase I Study of the HS-10352 in Patients With Advanced Breast Cancer
|
Phase 1 | |
Completed |
NCT04307407 -
Exercise in Breast Cancer Survivors
|
N/A | |
Recruiting |
NCT03544762 -
Correlation of 16α-[18F]Fluoro-17β-estradiol PET Imaging With ESR1 Mutation
|
Phase 3 | |
Terminated |
NCT02482389 -
Study of Preoperative Boost Radiotherapy
|
N/A | |
Enrolling by invitation |
NCT00068003 -
Harvesting Cells for Experimental Cancer Treatments
|
||
Completed |
NCT00226967 -
Stress, Diurnal Cortisol, and Breast Cancer Survival
|
||
Recruiting |
NCT06037954 -
A Study of Mental Health Care in People With Cancer
|
N/A | |
Recruiting |
NCT06006390 -
CEA Targeting Chimeric Antigen Receptor T Lymphocytes (CAR-T) in the Treatment of CEA Positive Advanced Solid Tumors
|
Phase 1/Phase 2 | |
Recruiting |
NCT06019325 -
Rhomboid Intercostal Plane Block on Chronic Pain Incidence and Acute Pain Scores After Mastectomy
|
N/A |