Carboplatin and Paclitaxel Albumin-Stabilized Nanoparticle Formulation Before Surgery in Treating Patients With Locally Advanced or Inflammatory Triple Negative Breast Cancer
![]() |
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: NCT01525966 |
Recruitment Status :
Active, not recruiting
First Posted : February 3, 2012
Last Update Posted : July 13, 2021
|
- Study Details
- Tabular View
- Results Submitted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Inflammatory Breast Cancer Stage IIA Breast Cancer Stage IIIA Breast Cancer Stage IIIB Breast Cancer Stage IIIC Breast Cancer Triple-negative Breast Cancer Stage IIB Breast Cancer Estrogen Receptor Negative Progesterone Receptor Negative HER2/Neu Negative | Drug: carboplatin Drug: paclitaxel albumin-stabilized nanoparticle formulation Other: laboratory biomarker analysis | Phase 2 |

Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 69 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Phase II Trial of Neoadjuvant Chemotherapy With Carboplatin and NAB-Paclitaxel in Patients With Locally Advanced and Inflammatory Triple Negative Breast Cancer |
Actual Study Start Date : | February 15, 2012 |
Actual Primary Completion Date : | January 11, 2019 |
Estimated Study Completion Date : | January 14, 2022 |

Arm | Intervention/treatment |
---|---|
Experimental: Treatment (carboplatin and nab-paclitaxel)
Patients receive carboplatin IV over 30 minutes on day 1 and paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes once weekly. Treatment repeats every 28 days for 4 courses in the absence of disease progression or unacceptable toxicity.
|
Drug: carboplatin
Given IV
Other Names:
Drug: paclitaxel albumin-stabilized nanoparticle formulation Given IV
Other Names:
Other: laboratory biomarker analysis Correlative studies |
- pCR or Symmans 0-1 pathological response [ Time Frame: At completion of definitive surgery ]A two stage design using MD Anderson criteria of lack of evidence of any residual invasive tumor in breast and/or regional lymph node.
- Overall survival [ Time Frame: 5 years from completion of study treatment ]Estimated by the Kaplan-Meier method. The corresponding median survival times (with 90% confidence limits) will be determined.
- Progression-free survival [ Time Frame: 5 years from completion of study treatment ]Estimated by the Kaplan-Meier method. The corresponding median survival times (with 90% confidence limits) will be determined.
- Number of patients experiencing serious adverse events (SAEs) graded using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 [ Time Frame: 30 days after completion of study treatment ]SAEs will be characterized by type of adverse event and grade, and by the time of onset in relation to the first day of therapy for each cycle. Attribution of SAEs to treatment (unrelated, unlikely, possible, probable, or definite) will also be reported. The cumulative percentage of patients experiencing treatment-related SAEs and its relationship to treatment duration will also be reported.

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: | 19 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Patients must be diagnosed with locally advanced (T2 and higher with or without lymph node involvement), and/or inflammatory triple negative breast cancer
- Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control or abstinence) prior to study entry and for six months following duration of study participation; should a woman become pregnant or suspect that she is pregnant while participating on the trial, she should inform her treating physician immediately
- Tumor negative for expression of hormone receptors (< 10%) and not over-expressing HER2 by immunohistochemistry (IHC) (0-1), or in case of IHC of 2, negative by fluorescence in situ hybridization (FISH) or by alternative gene testing
- Bilirubin =< 1.5 mg/dL
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =< 2 x upper limit of normal
- Alkaline phosphatase =< 2 x upper limit of normal
- Platelets >= 100,000 cells/mm^3
- Hemoglobin > 9.0 g/dL
- Absolute neutrophil count (ANC) >= 1,500 cells/mm^3
- Creatinine =< 1.5 mg/dL is recommended; however, institutional norms are acceptable
- Left ventricular ejection fraction > 50%
- Women of childbearing potential and sexually active males must use an effective contraception method during treatment and for three months after completing treatment
- Negative serum or urine beta-human chorionic gonadotropin (hCG) pregnancy test screening for patients of childbearing potential
- All subjects must have the ability to understand and the willingness to sign a written informed consent
- No prior therapies are allowed for the treatment of the newly diagnosed breast cancer; patients with a prior diagnosis of malignancy treated >= 5 years ago are eligible, provided that they have not received prior taxanes or carboplatin as part of their prior treatment regimen, and that they meet all eligibility criteria
Exclusion Criteria:
- Known active hepatitis B or C
- Known active human immunodeficiency virus (HIV)
- Prior breast cancer or other invasive malignancy treated within 5 years
- Pregnancy
- Neuropathy > grade 1
- Any other intercurrent medical/psychological problem deemed exclusionary by the treating physician or investigators/primary investigator (PI)
- Subjects will be excluded who, in the opinion of the investigator, may not be able to comply with the safety monitoring requirements of the study

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): NCT01525966
United States, California | |
City of Hope Medical Center | |
Duarte, California, United States, 91010 | |
City of Hope- South Pasadena Cancer Center | |
South Pasadena, California, United States, 91030 |
Principal Investigator: | Yuan Yuan, MD, PhD | City of Hope Medical Center |
Responsible Party: | City of Hope Medical Center |
ClinicalTrials.gov Identifier: | NCT01525966 |
Other Study ID Numbers: |
11174 NCI-2012-00025 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) ) |
First Posted: | February 3, 2012 Key Record Dates |
Last Update Posted: | July 13, 2021 |
Last Verified: | July 2021 |
Breast Neoplasms Triple Negative Breast Neoplasms Inflammatory Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases Paclitaxel |
Albumin-Bound Paclitaxel Carboplatin Antineoplastic Agents, Phytogenic Antineoplastic Agents Tubulin Modulators Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action |