Chemotherapy Followed by Peripheral Stem Cell Transplantation in Treating Metastatic Triple-negative Breast Cancer
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ClinicalTrials.gov Identifier: NCT02183805 |
Recruitment Status :
Terminated
(Difficulty accruing subjects the study accrual was closed)
First Posted : July 8, 2014
Last Update Posted : July 23, 2021
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Condition or disease | Intervention/treatment | Phase |
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Carcinoma Breast Stage IV | Drug: Abraxane,Cyclophosphamide,Carboplatin | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 6 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Phase II Study of Chemotherapy Followed by Peripheral Stem Cell Transplantation as First Line Therapy for Metastatic Triple-negative Breast Cancer |
Actual Study Start Date : | June 17, 2014 |
Actual Primary Completion Date : | December 15, 2020 |
Actual Study Completion Date : | December 15, 2020 |

Arm | Intervention/treatment |
---|---|
Experimental: Metastatic triple negative breast cancer
Abraxane,Cyclophosphamide,Carboplatin
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Drug: Abraxane,Cyclophosphamide,Carboplatin
High dose chemotherapy: Abraxane, Cyclophosphamide, Carboplatin
Other Names:
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- Progression free Survival [ Time Frame: 24 months ]
- Overall Survival [ Time Frame: 24 months ]

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Ages Eligible for Study: | 18 Years to 65 Years (Adult, Older Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- Eastern Cooperative Oncology Group (ECOG) 0 or 1.
- Histologically or cytologically proven diagnosis of breast cancer with evidence of locally recurrent or metastatic disease.
- Documentation of estrogen and progestin receptor (ER/PR) negative status and HER2/neu receptor negative status (ie, FISH negative or immunohistochemistry 0 or +1).
- Obtained complete response or Good partial response after first line chemotherapy.
- Normal organ function required prior to study entry.
- Willingness to comply with treatment plans and other study procedures.
Exclusion Criteria:
- Uncontrolled central nervous system (CNS) involvement with disease
- Fertile women unwilling to use contraceptive techniques during treatment
- Females who are pregnant
- Organ dysfunction.
- Patients may not be receiving any other investigational agents.

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): NCT02183805
China, Guangdong | |
Sun Yat-sen University Cancer Center | |
Guangzhou, Guangdong, China, 510060 |
Principal Investigator: | Zhong-Yu Yuan, M.D. | Sun Yat-sen University |
Responsible Party: | Zhong-yu Yuan, Sun Yat-sen University Cancer Center, Sun Yat-sen University |
ClinicalTrials.gov Identifier: | NCT02183805 |
Other Study ID Numbers: |
SYSUCC-004 |
First Posted: | July 8, 2014 Key Record Dates |
Last Update Posted: | July 23, 2021 |
Last Verified: | July 2021 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
triple negative breast cancer autologous hematopoietic stem-cell transplantation |
Breast Neoplasms Triple Negative Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases Cyclophosphamide Carboplatin Albumin-Bound Paclitaxel Paclitaxel Immunosuppressive Agents Immunologic Factors |
Physiological Effects of Drugs Antirheumatic Agents Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Myeloablative Agonists Antineoplastic Agents, Phytogenic Tubulin Modulators Antimitotic Agents Mitosis Modulators |