A Phase 2 interventional study of Carboplatin and Paclitaxel in Breast Cancer and Triple Negative Breast Cancer, sponsored by University of Wisconsin, Madison. Completed at 6 sites in United States. Open to participants aged 18 Years to 74 Years. Per ClinicalTrials.gov, last updated 2026-02-13.
Sponsored by University of Wisconsin, Madison · Phase 2, Interventional, and Treatment
This is a phase II single-arm, open-label, prospective study to evaluate the efficacy of the low dose weekly Carboplatin/Paclitaxel followed by dose-dense Doxorubicin/Cyclophosphamide in subjects with triple-negative breast cancer in neoadjuvant settings.
1,219 studies on the registry are indexed under Triple Negative Breast Neoplasms; 446 are open to participants now.
This study's enrollment of 29 is below the median of 60 across 1,053 interventional studies indexed under Triple Negative Breast Neoplasms.
Browse Triple Negative Breast Neoplasms studies →University of Wisconsin, Madison is the lead sponsor of 1,188 studies on the registry; 181 are open to participants now.
Of its 157 completed or terminated interventional studies of FDA-regulated products, 118 (75%) have results posted.
Compared within Triple Negative Breast Neoplasms, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Breast Neoplasms. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Subjects must have or cytologically confirmed invasive breast cancer which meets the following criteria:
Non Pregnant. Women of must have a negative pregnancy test (HCG serum or urine) within 30 days prior to study registration and to be repeated if not done within 7 days of starting chemotherapy.
Female subjects must meet one of the following:
Male subjects, even if surgically sterilized (i.e., status post vasectomy) must agree to one of the following:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
HER2 is a protein, made from the ERBB2 gene, that drives the growth of some cancers. A study may look for a level of the protein, extra copies of the gene, or a particular change in it.
In breast cancer, protein tests are read as HER2-positive, HER2-low or HER2-negative; other cancers use their own rules. Check which test result the study requires.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HER2
HER2 is a protein, made from the ERBB2 gene, that drives the growth of some cancers. A study may look for a level of the protein, extra copies of the gene, or a particular change in it.
In breast cancer, protein tests are read as HER2-positive, HER2-low or HER2-negative; other cancers use their own rules. Check which test result the study requires.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Adjuvant and neoadjuvant
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
LVEF (left ventricular ejection fraction)
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Regimen A (cycles 1-4): Paclitaxel 80 mg/m2; administer intravenously on day 1, 8, 15 of cycles 1, 2, 3, 4 (every 3 weeks) Carboplatin AUC=2 (dose calculation by determining creatine clearance with Cockroft Gault using adjusted body weight); administer intravenously on day 1, 8, 15 of cycles 1, 2, 3, 4 (every 3 weeks) Regimen B (cycles 5-8): Doxorubicin 60 mg/m2; administer intravenously on day 1 of cycles 5, 6, 7, 8 (every 2 weeks) Cyclophosphamide 600 mg/m2; administer intravenously on day 1 of cycles 5, 6, 7, 8 (every 2 weeks) Pegfilgrastim (for use on Doxorubicin/Cyclophosphamide cycles only), filgrastim, or biosimilar support on day 2 - 3 of cycles 5, 6, 7, 8 (every 2 weeks) There is a one week break between the end of cycle 4 and the beginning of cycle 5. Regimen C: Surgical intervention for management of breast cancer diagnosis; procedure and timing as determined by surgical team.
Drug: Carboplatin · Drug: Paclitaxel · Drug: Doxorubicin · Drug: Cyclophosphamide · Drug: Pegfilgrastim · Drug: Filgrastim
Carboplatin is a platinum compound alkylating agent which covalently binds to DNA; interferes with the function of DNA by producing interstrand DNA cross-links.
Paclitaxel promotes microtubule assembly by enhancing the action of tubulin dimers, stabilizing existing microtubules, and inhibiting their disassembly, interfering with the late G2 mitotic phase, and inhibiting cell replication. In addition, the drug can distort mitotic spindles, resulting in the breakage of chromosomes. Paclitaxel may also suppress cell proliferation and modulate immune response.
Inhibition of DNA and RNA synthesis by intercalation between DNA base pairs by inhibition of topoisomerase II and by steric obstruction. Doxorubicin intercalates at points of local uncoiling of the double helix. Although the exact mechanism is unclear, it appears that direct binding to DNA (intercalation) and inhibition of DNA repair (topoisomerase II inhibition) result in blockade of DNA and RNA synthesis and fragmentation of DNA. Doxorubicin is also a powerful iron chelator; the iron-doxorubicin complex can bind DNA and cell membranes and produce free radicals that immediately cleave the DNA and cell membranes.
Also known as: Adriamycin, Doxil, Caelyx, Myocet
Cyclophosphamide is an alkylating agent that prevents cell division by cross-linking DNA strands and decreasing DNA synthesis. It is a cell cycle phase nonspecific agent. Cyclophosphamide also possesses potent immunosuppressive activity. Cyclophosphamide is a prodrug that must be metabolized to active metabolites in the liver.
Also known as: cytophosphane
Pegfilgrastim provides growth factor support in a single dose. It stimulates bone marrow to create neutrophils for patients undergoing chemotherapy.
Filgrastim provides growth factor support in multiple doses. It stimulates bone marrow to create neutrophils for patients undergoing chemotherapy.
Number and Percentage of Participants With Pathologic Complete Response (pCR) Rate
pCR is defined as the absence of residual invasive cancer on hematoxylin and eosin evaluation of the complete resected breast specimen and all sampled regional lymph nodes following completion of neoadjuvant systemic therapy. pCR will be assessed according to RECIST 1.1 criteria. The point estimate of the primary efficacy endpoint pCR and its exact 95% confidence intervals (CI) will be calculated. In evaluating pCR, subjects with missing data will be considered non-responders.
Time frame: Up to 2 years
Number of Cycles of Chemotherapy Administered
To evaluate the number of cycles low dose weekly Carboplatin/Paclitaxel regimen administered. Simple descriptive statistics will be used to describe the number of cycles of chemotherapy administered.
Time frame: Week 12 to week 18 to account for possible delays
Total Dose of Chemotherapy Administered
To evaluate the total dose of weekly Carboplatin/Paclitaxel regimen administered. Simple descriptive statistics will be used to describe the dose amount of chemotherapy administered.
Time frame: Week 12 to week 18 to account for possible delays
Delays of Administered Chemotherapy
To evaluate the delays of low dose weekly Carboplatin/Paclitaxel regimen administered. Simple descriptive statistics will be used to describe the delays of chemotherapy administered.
Time frame: Week 12 to week 18 to account for possible delays
Number of Treatment-related Toxicities Experienced by Participants
Count of any treatment-related toxicities from the low dose weekly Carboplatin/Paclitaxel regimen. Will be assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0
Time frame: Up to week 12
Recurrence-free Survival (RFS)
To evaluate two-year RFS after treatment with this neoadjuvant regimen. Count of participants without evidence for local-regional or distant relapse, second primary, or death will be reported.
Time frame: Up to 2 years
Overall Survival (OS)
To evaluate the two-year overall survival after treatment with this neoadjuvant regimen. Count of participants who achieved 2 year OS is reported.
Time frame: Up to 2 years
| Milestone | Neoadjuvant Chemotherapy |
|---|---|
| Started | 29 |
| Completed | 21 |
| Not completed | 8 |
| Withdrew: Withdrawal by subject | 4 |
| Withdrew: Adverse event | 1 |
| Withdrew: Pt withdrawn per dsmc request | 1 |
| Withdrew: Completed all chemo cycles, however died prior to definitive surgery | 1 |
| Withdrew: No detail provided | 1 |
pCR is defined as the absence of residual invasive cancer on hematoxylin and eosin evaluation of the complete resected breast specimen and all sampled regional lymph nodes following completion of neoadjuvant systemic therapy. pCR will be assessed according to RECIST 1.1 criteria. The point estimate of the primary efficacy endpoint pCR and its exact 95% confidence intervals (CI) will be calculated. In evaluating pCR, subjects with missing data will be considered non-responders.
| Participants | Neoadjuvant Chemotherapy |
|---|---|
| Number and Percentage of Participants With Pathologic Complete Response (pCR) Rate | 8 |
To evaluate the number of cycles low dose weekly Carboplatin/Paclitaxel regimen administered. Simple descriptive statistics will be used to describe the number of cycles of chemotherapy administered.
| Participants | Neoadjuvant Chemotherapy |
|---|---|
| 4 complete cycles | 25 |
| Less than 1 cycle | 3 |
To evaluate the total dose of weekly Carboplatin/Paclitaxel regimen administered. Simple descriptive statistics will be used to describe the dose amount of chemotherapy administered.
| doses administered | Neoadjuvant Chemotherapy |
|---|---|
| Carboplatin dose AUC of 2.0 - full dose | 285 |
| paclitaxel dose: 80 mg/m2 - full dose | 279 |
| Carboplatin reduced dose AUC 1.6 | 15 |
| Carboplatin reduced dose AUC 1.5 | 2 |
| Paclitaxel - reduced dose | 23 |
To evaluate the delays of low dose weekly Carboplatin/Paclitaxel regimen administered. Simple descriptive statistics will be used to describe the delays of chemotherapy administered.
| Participants | Neoadjuvant Chemotherapy |
|---|---|
| Participants with no delays | 12 |
| Participants with single 1 week delay | 7 |
| Participants with single 2 week delay | 3 |
| Participants with more than 1 delay | 4 |
Count of any treatment-related toxicities from the low dose weekly Carboplatin/Paclitaxel regimen. Will be assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0
| treatment related toxicities | Neoadjuvant Chemotherapy |
|---|---|
| Neutrophil count decreased | 26 |
| Anemia | 27 |
| Platelet count decreased | 22 |
| White blood cells decreased | 25 |
| ALT increased | 9 |
| AST increased | 8 |
| Creatinine increased | 2 |
| Bilirubin increased | 1 |
To evaluate two-year RFS after treatment with this neoadjuvant regimen. Count of participants without evidence for local-regional or distant relapse, second primary, or death will be reported.
| Participants | Neoadjuvant Chemotherapy |
|---|---|
| No evidence of disease | 18 |
| Alive, recurrent disease | 2 |
| Deceased, recurrent disease | 2 |
| Alive, unknown disease status | 2 |
To evaluate the two-year overall survival after treatment with this neoadjuvant regimen. Count of participants who achieved 2 year OS is reported.
| Participants | Neoadjuvant Chemotherapy |
|---|---|
| 2 year survival | 22 |
| Deceased | 3 |
Collected over 2 years from starting study treatment. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Neoadjuvant Chemotherapy | 3/28 (10.7%) | 17/28 (60.7%) | 10/10 (100%) |
| Event | Neoadjuvant Chemotherapy |
|---|---|
| Neutrophil count decreasedInvestigations | 15/28 |
| Febrile neutropeniaBlood and lymphatic system disorders | 5/28 |
| AnemiaBlood and lymphatic system disorders | 4/28 |
| Atrial fibrilationCardiac disorders | 2/28 |
| CholecystitisHepatobiliary disorders | 2/28 |
| Lung infectionInfections and infestations | 2/28 |
| platelet count decreasedInvestigations | 2/28 |
| White blood cell decreasedInvestigations | 2/28 |
| Thromboembolic eventVascular disorders | 2/28 |
| Sinus tachycardiaCardiac disorders | 1/28 |
| Event | Neoadjuvant Chemotherapy |
|---|---|
| AnemiaBlood and lymphatic system disorders | 10/10 |
| Neutrophil count decreasedInvestigations | 10/10 |
| White blood cell decreasedInvestigations | 10/10 |
| FatigueGeneral disorders | 10/10 |
| Lymphocyte count decreasedBlood and lymphatic system disorders | 9/10 |
| Platelet count decreasedInvestigations | 8/10 |
| NauseaGastrointestinal disorders | 8/10 |
| DysgeusiaGastrointestinal disorders | 8/10 |
| ConstipationGastrointestinal disorders | 7/10 |
| Peripheral sensory neuropathyNervous system disorders | 7/10 |
1 participant withdrew after being assigned but prior to treatment. Characteristics were collected for baseline hence 29 baseline participants being reported
| Age, Customized(Participants) | Neoadjuvant Chemotherapy |
|---|---|
| 30-39 | 5 |
| 40-49 | 7 |
| 50-59 | 12 |
| 60-69 | 3 |
| 70-79 | 1 |
| 80-89 | 1 |
| Unknown | 0 |
| Sex: Female, Male(Participants) | Neoadjuvant Chemotherapy |
|---|---|
| Female | 27 |
| Male | 2 |
| Ethnicity (NIH/OMB)(Participants) | Neoadjuvant Chemotherapy |
|---|---|
| Hispanic or Latino | 0 |
| Not Hispanic or Latino | 29 |
| Unknown or Not Reported | 0 |
| Race (NIH/OMB)(Participants) | Neoadjuvant Chemotherapy |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 5 |
| White | 24 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
| Region of Enrollment(participants) | Neoadjuvant Chemotherapy |
|---|---|
| United States | 29 |
PDFs hosted by the registry, ClinicalTrials.gov.
This study is completed, as verified in Jan 2023. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Carboplatin · Paclitaxel · Doxorubicin · Cyclophosphamide
Triple Negative Breast Neoplasms →
University of Wisconsin, Madison →