Trial for Locally Advanced Breast Cancer Using Vorinostat Plus Chemotherapy
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00574587 |
Recruitment Status :
Completed
First Posted : December 17, 2007
Results First Posted : September 18, 2020
Last Update Posted : October 14, 2020
|
- Study Details
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Breast Cancer | Drug: Vorinostat Drug: Paclitaxel Drug: Trastuzumab Drug: Doxorubicin Drug: Cyclophosphamide Procedure: Surgery | Phase 1 Phase 2 |
This is a phase I-II trial in which patients with stage IIB-IIIC breast cancer will receive:
- Neoadjuvant weekly paclitaxel (80 mg/m2 IV weekly x 12 weeks) plus vorinostat (200 or 300 mg PO BID on days 1-3 each paclitaxel dose) and trastuzumab (4 mg/kg loading dose, 2 mg/kg IV weekly x 12 total doses if HER2 positive, followed by:
- Doxorubicin (60 mg/m2) plus cyclophosphamide (600 mg/m2) every 2 weeks x 4 cycles (plus G-CSF), followed by:
- Surgery (lumpectomy or mastectomy)
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 55 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Phase I-II Trial of Vorinostat Plus Weekly Paclitaxel (+/- Trastuzumab) Followed by Doxorubicin-cyclophosphamide in Patients With Locally Advanced Breast Cancer |
Study Start Date : | December 2007 |
Actual Primary Completion Date : | May 2014 |
Actual Study Completion Date : | May 2014 |

Arm | Intervention/treatment |
---|---|
Experimental: Vorinostat Plus Paclitaxel
Vorinostat (PO days 1-3) plus weekly paclitaxel x 12 weeks (and trastuzumab if HER2-positive), followed by doxorubicin-cyclophosphamide every 2 weeks x 4 cycles, followed by surgery
|
Drug: Vorinostat
Vorinostat 200 or 300 mg PO BID on days 1-3 of each weekly paclitaxel dose
Other Name: Zolinza Drug: Paclitaxel Paclitaxel 80 mg/m2 weekly for 12 weeks
Other Name: Taxol Drug: Trastuzumab Trastuzumab (if HER2-positive) 4 mg/kg, then 2 mg/kg weekly for 12 weeks including loading dose
Other Name: Perception Drug: Doxorubicin Doxorubicin 60 mg/m2 every 2 weeks for 8 weeks
Other Name: Adriamycin Drug: Cyclophosphamide Cyclophosphamide 600 mg/m2 every 2 weeks for 8 weeks
Other Name: Cytoxan Procedure: Surgery Surgical excision of tumor from breast
Other Name: Mastectomy or lumpectomy |
- Recommended Phase II Dose of Vorinostat in Combination With Weekly Paclitaxel/Trastuzumab [ Time Frame: 3 weeks ]Dose limiting toxicity in cycle 1
- Pathological Complete Response (CR) Rate in Patients With Her2/Neu Positive Locally Advanced Breast Cancer. [ Time Frame: 6 months ]Pathological Complete Response (CR) defined as absence of invasive cancer at surgery

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years to 100 Years (Adult, Older Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Histologically or cytologically confirmed adenocarcinoma of the breast associated with the following stages: IIB, IIIA, IIIB or IIIC.
- Tumor must be Her2/neu positive
- No prior chemotherapy, radiation or definitive therapeutic surgery
Exclusion Criteria:
- May not be receiving any other investigational agents
- Uncontrolled intercurrent illness

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00574587
United States, New York | |
Montefiore Medical Center | |
Bronx, New York, United States, 10461 |
Principal Investigator: | Joseph Sparano, MD | Montefiore Medical Center |
Responsible Party: | Joseph Sparano, Professor, Oncology, Albert Einstein College of Medicine |
ClinicalTrials.gov Identifier: | NCT00574587 |
Other Study ID Numbers: |
07-10-374 NYCC1 ( Other Identifier: Montefiore Medical Center ) NCI-2013-01216 ( Registry Identifier: CTRP ) |
First Posted: | December 17, 2007 Key Record Dates |
Results First Posted: | September 18, 2020 |
Last Update Posted: | October 14, 2020 |
Last Verified: | September 2020 |
Vorinostat Neoadjuvant Chemotherapy |
Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases Paclitaxel Cyclophosphamide Doxorubicin Trastuzumab Vorinostat Antineoplastic Agents, Phytogenic Antineoplastic Agents Tubulin Modulators Antimitotic Agents Mitosis Modulators |
Molecular Mechanisms of Pharmacological Action Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Antirheumatic Agents Antineoplastic Agents, Alkylating Alkylating Agents Myeloablative Agonists Antibiotics, Antineoplastic Topoisomerase II Inhibitors Topoisomerase Inhibitors Enzyme Inhibitors Antineoplastic Agents, Immunological Histone Deacetylase Inhibitors |