A Phase 2 interventional study of carboplatin and paclitaxel albumin-stabilized nanoparticle formulation in Inflammatory Breast Cancer, Stage IIA Breast Cancer and Stage IIIA Breast Cancer, sponsored by City of Hope Medical Center. Active, not recruiting at 2 sites in United States. Open to female participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2026-03-30.
Sponsored by City of Hope Medical Center · Phase 2, Interventional, and Treatment
This phase II trial studies how well carboplatin and nab-paclitaxel before surgery work in treating patients with triple negative breast cancer that is inflammatory or has spread from where it started to nearby tissue or lymph nodes. Drugs used in chemotherapy, such as carboplatin and nab-paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving chemotherapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed.
PRIMARY OBJECTIVES:
I. To test the hypothesis that carboplatin + nab-paclitaxel (paclitaxel albumin-stabilized nanoparticle formulation) therapy will demonstrate a promising neoadjuvant pathologic complete response (pCR) rate for eligible patients.
II. To test the hypothesis that carboplatin + nab-paclitaxel therapy will demonstrate a promising Symmans 0-1 pathological response rate for eligible patients.
SECONDARY OBJECTIVES:
I To evaluate the overall survival and event-free survival of eligible patients treated with carboplatin + nab-paclitaxel neoadjuvant chemotherapy.
II. To evaluate the toxicities and tolerance of carboplatin + nab-paclitaxel therapy in this patient population.
III. To evaluate the role of laboratory correlates in response, toxicity and survival endpoints.
IV. To procure tissue and perform analysis of gene and protein expression profiles of pre-treatment primary tumor (estimated success rate: 80%) and residual tumors (25%) and lymph nodes including the study of tumor niche (50%), studying sequential assessment of cellular characteristics and gene and protein expression profiles.
V. To identify specific mutations in tumor deoxyribonucleic acid (DNA) in comparison to adjacent tissue and germ line DNA procured prior to, during, and subsequent to neoadjuvant chemotherapy, and to detect/measure, as feasible, the presence of such mutations in fragmented circulating DNA from plasma, and to correlate these mutations with the presence/characteristics of circulating tumor cells in order to identify prognostic and predictive indicators of persisting/relapsed disease and targets for therapy.
VI. To assess ribonucleic acid (RNA) (using Mammaprint/Blueprint and 44,000 Agilent platform gene array), (micro) miRNA and exosome and protein profiles in tumor, adjacent tissue and plasma prior to, during, and at completion of neoadjuvant chemotherapy in order to establish prognostic and predictive indicators of outcome, markers of persistent/relapsed disease, and targets for therapy.
VII. To analyze tumor DNA and genomic DNA from plasma by microarray and reverse transcriptase (RT)-polymerase chain reaction (PCR) analysis to assess copy numbers/single nucleotide polymorphisms (SNP)/genomic polymorphisms in genes for the purposes of establishing prognostic and predictive indicators of outcomes; markers of persistence/relapse disease, drug resistance, and drug metabolism; and targets of therapy.
VIII. To assess the prognostic and predictive value of conventional pathological features (stage, estrogen and progesterone receptor and human epidermal growth factor receptor [HER-2] status, presence of lymphovascular invasion, high grade tumor status) in comparison to such values derived from the molecular approaches.
IX. To procure tumor from the primary and definitive surgical specimen for the purpose of establishing breast cancer stem cell lines.
X. To procure blood samples for the purpose of identifying and characterizing circulating tumor cells.
OUTLINE: Patients receive carboplatin intravenously (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.
After completion of study treatment, patients are followed up every 3 months for 4 years and then every 6 months for 1 year and then periodically thereafter.
84 studies on the registry are indexed under Inflammatory Breast Neoplasms; 7 are open to participants now.
This study's enrollment of 67 is above the median of 54 across 74 interventional studies indexed under Inflammatory Breast Neoplasms.
Browse Inflammatory Breast Neoplasms studies →City of Hope Medical Center is the lead sponsor of 670 studies on the registry; 181 are open to participants now.
Of its 30 completed or terminated interventional studies of FDA-regulated products, 12 (40%) have results posted.
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Exclusion Criteria:
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 · Drug: paclitaxel albumin-stabilized nanoparticle formulation · Other: laboratory biomarker analysis
Given IV
Also known as: Carboplat, CBDCA, JM-8, Paraplat, Paraplatin
Given IV
Also known as: ABI-007, nab paclitaxel, nab-paclitaxel, nanoparticle albumin-bound paclitaxel
Correlative studies
pCR Rate After Treatment.
pCR is RCB 0 by Symmans criteria. The goal of the study is a detection of an increase in rate of pathological complete remission (pCR) from 20% (historical) to 38%
Time frame: At completion of definitive surgery, up to six months from initial treatment
Residual Cancer Burden (RCB) by Symmans Criteria.
Categorization of the outcome of the treatment at completion of definitive surgery by Symmans criteria. "The index score is derived from the largest area and cellularity of residual invasive primary cancer and the number of involved lymph nodes and size of largest metastasis. pCR (stage yp-T0/is, ypN0) has RCB = 0; and RCB class is minimal (RCB-I), moderate (RCB-II), or extensive (RCB-III), on the basis of predefined cut points of 1.36 and 3.28 index scores.) Symmans WF, Wei C, Gould R, et al. J Clin Oncol 35:1049-1060, 2017. Symmans WF, Peintinger F, Hatzis C et al. J Clin Oncol 25:4414-4422, 2007. Order of scale is RCB0 is best, then I, II, III, worse; progressive is the worst.
Time frame: At completion of definitive surgery, up to six months post-commencement of study chemotherapy.
Adjuvant Radiation
After adjuvant chemotherapy and before surgery, some patients were given adjuvant radiation.
Time frame: Up to 6 months
Scope of Surgery
After having received adjuvant chemotherapy, and possibly radiation, patients underwent surgery.
Time frame: Up to 6 months.
Overall Survival
Estimated by the Kaplan-Meier method. Three-year point estimate and 95% confidence interval based on the Greenwood variance, with log-log transformation, will be provided. The corresponding median survival times (with 90% confidence limits) will be determined. Patients' survival times will be measured from the initial date of treatment to the recorded date of death, or most recent follow-up at the end-of-study date.
Time frame: Up to three years post-commencement of chemotherapy.
Progression-free Survival
Estimated by the Kaplan-Meier method. Three-year point estimate and 95% confidence interval based on the Greenwood variance, with log-log transformation, will be provided. Patients' survival times will be measured from the initial date of treatment to the recorded date of progression or death. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
Time frame: Up to three years.
Participants for this study will be recruited from among patients undergoing treatment at City of Hope Cancer Center for stage II/III -- including inflammatory-- breast adenocarcinoma. Patients will be recruited through encounters by the Breast Oncologists in the Department of Medical Oncology and/or Breast Surgical Oncologists of the Department of General Oncological Surgery.
| Milestone | Treatment (Carboplatin and Nab-paclitaxel) |
|---|---|
| Started | 67 |
| Completed | 67 |
| Not completed | 0 |
pCR is RCB 0 by Symmans criteria. The goal of the study is a detection of an increase in rate of pathological complete remission (pCR) from 20% (historical) to 38%
| Participants | Treatment (Carboplatin and Nab-paclitaxel) |
|---|---|
| pCR | 32 |
| not reached pCR | 35 |
Categorization of the outcome of the treatment at completion of definitive surgery by Symmans criteria. "The index score is derived from the largest area and cellularity of residual invasive primary cancer and the number of involved lymph nodes and size of largest metastasis. pCR (stage yp-T0/is, ypN0) has RCB = 0; and RCB class is minimal (RCB-I), moderate (RCB-II), or extensive (RCB-III), on the basis of predefined cut points of 1.36 and 3.28 index scores.) Symmans WF, Wei C, Gould R, et al. J Clin Oncol 35:1049-1060, 2017. Symmans WF, Peintinger F, Hatzis C et al. J Clin Oncol 25:4414-4422, 2007. Order of scale is RCB0 is best, then I, II, III, worse; progressive is the worst.
| Participants | Treatment (Carboplatin and Nab-paclitaxel) |
|---|---|
| achieved pCR (RCB 0); no residual disease | 32 |
| had RCB I; minimal residual disease | 10 |
| had RCB II; moderate residual disease | 19 |
| had RCB III; extensive residual disease | 5 |
| Progressed | 1 |
After adjuvant chemotherapy and before surgery, some patients were given adjuvant radiation.
| Participants | Treatment (Carboplatin and Nab-paclitaxel) |
|---|---|
| Radiation before surgery | 37 |
| No radiation was given before surgery | 29 |
| No radiation and no surgery | 1 |
After having received adjuvant chemotherapy, and possibly radiation, patients underwent surgery.
| Participants | Treatment (Carboplatin and Nab-paclitaxel) |
|---|---|
| Lumpectomy | 19 |
| Mastectomy | 47 |
| No surgery performed due to distant metastasis | 1 |
Estimated by the Kaplan-Meier method. Three-year point estimate and 95% confidence interval based on the Greenwood variance, with log-log transformation, will be provided. The corresponding median survival times (with 90% confidence limits) will be determined. Patients' survival times will be measured from the initial date of treatment to the recorded date of death, or most recent follow-up at the end-of-study date.
| percentage of surviving patients: 3-yr | Treatment (Carboplatin and Nab-paclitaxel) |
|---|---|
| Overall Survival | 90.2 (77.8 to 95.8) |
Estimated by the Kaplan-Meier method. Three-year point estimate and 95% confidence interval based on the Greenwood variance, with log-log transformation, will be provided. Patients' survival times will be measured from the initial date of treatment to the recorded date of progression or death. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
| percentage of pts | Treatment (Carboplatin and Nab-paclitaxel) |
|---|---|
| Progression-free Survival | 87.3 (58.5 to 90.2) |
Collected over Serious and Other Adverse Events monitored through completion of treatment, up to 6 years, 7 months. All-Cause Mortality monitored up to 8 years.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Treatment (Carboplatin and Nab-paclitaxel) | 5/67 (7.5%) | 5/67 (7.5%) | 67/67 (100%) |
| Event | Treatment (Carboplatin and Nab-paclitaxel) |
|---|---|
| 10012174-DehydrationMetabolism and nutrition disorders | 2/67 |
| 10016288-Febrile neutropeniaBlood and lymphatic system disorders | 1/67 |
| 10016558-FeverGeneral disorders | 1/67 |
| 10046571-Urinary tract infectionInfections and infestations | 1/67 |
| 10042613-Surgical and medical procedures - Other, specifySurgical and medical procedures | 1/67 |
| Event | Treatment (Carboplatin and Nab-paclitaxel) |
|---|---|
| 10016256-FatigueGeneral disorders | 64/67 |
| 10002272-AnemiaBlood and lymphatic system disorders | 63/67 |
| 10029366-Neutrophil count decreasedInvestigations | 58/67 |
| 10049182-White blood cell decreasedInvestigations | 55/67 |
| 10034620-Peripheral sensory neuropathyNervous system disorders | 53/67 |
| 10020772-HypertensionVascular disorders | 52/67 |
| 10035528-Platelet count decreasedInvestigations | 41/67 |
| 10028813-NauseaGastrointestinal disorders | 40/67 |
| 10001760-AlopeciaSkin and subcutaneous tissue disorders | 40/67 |
| 10001551-Alanine aminotransferase increasedInvestigations | 31/67 |
Eligibility criteria included: Locally advanced (T2 and higher with or without lymph node involvement), and/or inflammatory breast cancer; triple negative biology only. Tumor negative for expression of hormone receptors (IHC \< 10%) and not overexpressing HER2 by IHC (O-1), or, in case of IHC of 2, negative by FISH or by alternative gene testing. Greater than 18 years of age, female. Adequate organ function as specified in the protocol.
| Age, Continuous(years) | Treatment (Carboplatin and Nab-paclitaxel) |
|---|---|
| Median | 52 (28 to 79) |
| Sex: Female, Male(Participants) | Treatment (Carboplatin and Nab-paclitaxel) |
|---|---|
| Female | 67 |
| Male | 0 |
| Race/Ethnicity, Customized(Participants) | Treatment (Carboplatin and Nab-paclitaxel) |
|---|---|
| Non-Hispanic White | 35 |
| Hispanic | 24 |
| Asian | 4 |
| African American | 1 |
| Other | 3 |
| Region of Enrollment(participants) | Treatment (Carboplatin and Nab-paclitaxel) |
|---|---|
| United States | 67 |
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Inflammatory Breast Neoplasms→
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