Breast CancerPhase 2NCT03301350
Neoadjuvant Carbo/Paclitaxel Followed by Doxorubicin/Cyclophosphamide in Breast Cancer
A Phase 2 study testing Carboplatin, Paclitaxel and Doxorubicin in people with Breast Cancer and Triple Negative Breast Cancer, run by University of Wisconsin, Madison at 6 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 74 years
- Conditions the study is for
- Breast Cancer, Triple Negative Breast Cancer
- What is being tested?
- Carboplatin, Paclitaxel and Doxorubicin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 6 sitesUnited States
- Study dates
- 7 Nov 2017to 7 Feb 2022
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 74 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects must have histologically or cytologically confirmed invasive breast cancer which meets the following criteria:
- Estrogen Receptor (ER) and Progesterone Receptor (PR)-negative as defined by local standard clinical immunohistochemistry (IHC) < 1%.
- HER2-negative using local standard testing. Negative is defined as IHC 0 or 1+ (if 2+, must reflex to ISH method). If ISH method is used, ratio < 2 is considered negative.
- Clinical tumor size of at least 2.1 cm (T2) by palpation or imaging, regardless of the ipsilateral regional lymph node status, or any tumor size but with ipsilateral regional lymph nodes involved by the tumor (any T if ipsilateral regional node positive). Subjects with inflammatory breast cancer are eligible. If bilateral breast cancer is present, the subject is eligible if the contralateral tumor is DCIS only (without any invasive disease on biopsy) or another invasive breast cancer of any size that is also ER, PR and HER2 negative.
- Any radiographic abnormal ipsilateral regional lymph nodes or any clinically concerning ipsilateral regional lymph nodes with the exception of internal mammary nodes should be sampled with percutaneous biopsy, but no sentinel axillary lymph node mapping/biopsy is allowed before chemotherapy. If clinically node negative (cNO), pre-chemotherapy ipsilateral sentinel axillary lymph node mapping/biopsy is not allowed.
- Candidate for neoadjuvant chemotherapy.
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- Age > 18 years and < 75 years
- ECOG Performance Status < 1.
- Left ventricular ejection fraction (LVEF) ≥ LLN (per institutional normal) determined by
- Adequate organ and marrow function as determined by study protocol
- Non Pregnant. Women of childbearing potential 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:
- Natural postmenopausal before the screening visit defined as no menses at any time in the preceding 12 consecutive months, or
- Prior bilateral oophorectomy or bilateral tubal ligation, or
- If they are of childbearing potential, agree to practice two effective methods of contraception per discussion with the treating physicians from
- Male subjects, even if surgically sterilized (i.e., status post vasectomy) must agree to one of the following:
- Practice effective barrier contraception during the entire study treatment period and through 90 days after the last study drug dose, or
- Agree to practice true abstinence when this is in line with the preferred and usual lifestyle of the subject. (Periodic abstinence (e.g., calendar, ovulation, symptothermal, postovulation methods] and withdrawal are not acceptable methods of contraception.)
- Ability to understand a written informed consent document, and the willingness to sign it.
Who cannot join
- Prior chemotherapy or radiation therapy for invasive breast cancer within 6 months before registration.
- Prior investigational drugs or interventions for invasive breast cancer within 6 months before registration are not allowed. Prior participation in window-of-opportunity trials without therapeutic intent is allowed if intervention is no more than 3 weeks duration.
- Stage IV metastatic breast cancer
- History of allergic reactions attributed to compounds of similar chemical composition to chemotherapy to be used in this study.
- Breastfeeding women. Cytotoxic chemotherapy is drug with the potential for teratogenic or abortifacient effects. Due to unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with cytotoxic chemotherapy, breastfeeding should be discontinued.
- Baseline peripheral neuropathy of severity > grade 1
- Other invasive cancer diagnosis within the past 5 years other than non-melanoma skin cancer.
- Prior axillary lymph node dissection that preclude patient from surgical evaluation of axillary lymph node status.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
University of Wisconsin Carbone Cancer Center
Madison, Wisconsin, 53792
Columbia St. Mary's Cancer Center
Milwaukee, Wisconsin, 53211
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
Swedish American Hospital
Rockford, Illinois, 61104
ProHealth Care
Waukesha, Wisconsin, 53188
Aspirus Regional Cancer Center Wausau
Wausau, Wisconsin, 54401
About this study
Official title: A Phase II Study of Neoadjuvant Carboplatin/Paclitaxel Followed by Dose-Dense Doxorubicin/Cyclophosphamide in Patients With Hormone Receptor Negative, HER2 Receptor Negative Breast Cancer
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.
- Conditions
- Breast Cancer, Triple Negative Breast Cancer
- Being tested
- Carboplatin, Paclitaxel, Doxorubicin, Cyclophosphamide, Pegfilgrastim
- Medical subject headings
- Breast Neoplasms, Triple Negative Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CarboplatinDrug
Carboplatin is a platinum compound alkylating agent which covalently binds to DNA; interferes with the function of DNA by producing interstrand DNA cross-links.
PaclitaxelDrug
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.
DoxorubicinDrug
Also called Adriamycin, Doxil, Caelyx, Myocet
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.
CyclophosphamideDrug
Also called cytophosphane
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.
PegfilgrastimDrug
Pegfilgrastim provides growth factor support in a single dose. It stimulates bone marrow to create neutrophils for patients undergoing chemotherapy.
FilgrastimDrug
Filgrastim provides growth factor support in multiple doses. It stimulates bone marrow to create neutrophils for patients undergoing chemotherapy.
| Study group | Role | What they receive |
|---|---|---|
| Neoadjuvant Chemotherapy | Experimental | 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. Receives: Drug: Carboplatin; Drug: Paclitaxel; Drug: Doxorubicin; Drug: Cyclophosphamide; Drug: Pegfilgrastim; Drug: Filgrastim |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 2 years
Secondary outcomes (6)
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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: Up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2017
- Study start7 Nov 2017
- Primary completion23 Mar 2020
- Study completion7 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by University of Wisconsin, MadisonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kari Wisinski, MD, Principal investigator, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03301350
- Sponsor's protocol ID
- 2017-0547
- Other IDs
- NCI-2017-01705, 2017-0547, A534260, SMPH\MEDICINE\HEM-ONC, Protocol Version 11/26/2019
- Status last verified
- Jan 2023
- First submitted
- 29 Sep 2017
- Last updated
- 13 Feb 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of Neoadjuvant Carboplatin/Paclitaxel Followed by Dose-Dense Doxorubicin/Cyclophosphamide in Patients With Hormone Receptor Negative, HER2 Receptor Negative Breast Cancer
- ClinicalTrials.gov ID
- NCT03301350
- Acronym / sponsor ID
- 2017-0547
- Conditions
- Breast Cancer, Triple Negative Breast Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Study start
- 7 Nov 2017 (actual)
- Primary completion
- 23 Mar 2020 (actual)
- Study completion
- 7 Feb 2022 (actual)
- First posted
- 4 Oct 2017 (actual)
- Results
- Posted 1 Feb 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Neoadjuvant Chemotherapy | Experimental | Drug: Carboplatin, Drug: Paclitaxel, Drug: Doxorubicin, Drug: Cyclophosphamide, Drug: Pegfilgrastim, Drug: FilgrastimRegimen 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. |
Who may qualify
- Ages
- 18 to 74 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- Subjects must have histologically or cytologically confirmed invasive breast cancer which meets the following criteria:
- Candidate for neoadjuvant chemotherapy.
- Age > 18 years and < 75 years
- ECOG Performance Status < 1.
- Left ventricular ejection fraction (LVEF) ≥ LLN (per institutional normal) determined by
Key exclusion criteria (8 listed)
- Prior chemotherapy or radiation therapy for invasive breast cancer within 6 months before registration.
- Prior investigational drugs or interventions for invasive breast cancer within 6 months before registration are not allowed. Prior participation in window-of-opportunity trials without therapeutic intent is allowed if intervention is no more than 3 weeks duration.
- Stage IV metastatic breast cancer
- History of allergic reactions attributed to compounds of similar chemical composition to chemotherapy to be used in this study.
- Breastfeeding women. Cytotoxic chemotherapy is drug with the potential for teratogenic or abortifacient effects. Due to unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with cytotoxic chemotherapy, breastfeeding should be discontinued.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CarboplatinCarboplatin is a platinum compound alkylating agent which covalently binds to DNA; interferes with the function of DNA by producing interstrand DNA cross-links. | Drug | Neoadjuvant Chemotherapy |
| PaclitaxelPaclitaxel 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. | Drug | Neoadjuvant Chemotherapy |
| DoxorubicinAlso: Adriamycin, Doxil, Caelyx, MyocetInhibition 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. | Drug | Neoadjuvant Chemotherapy |
| CyclophosphamideAlso: cytophosphaneCyclophosphamide 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. | Drug | Neoadjuvant Chemotherapy |
| PegfilgrastimPegfilgrastim provides growth factor support in a single dose. It stimulates bone marrow to create neutrophils for patients undergoing chemotherapy. | Drug | Neoadjuvant Chemotherapy |
| FilgrastimFilgrastim provides growth factor support in multiple doses. It stimulates bone marrow to create neutrophils for patients undergoing chemotherapy. | Drug | Neoadjuvant Chemotherapy |
Primary outcome
Number and Percentage of Participants With Pathologic Complete Response (pCR) Rate
Time frame: Up to 2 years
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.
6 secondary outcomes
Number of Cycles of Chemotherapy Administered
Time frame: Week 12 to week 18 to account for possible delays
Total Dose of Chemotherapy Administered
Time frame: Week 12 to week 18 to account for possible delays
Delays of Administered Chemotherapy
Time frame: Week 12 to week 18 to account for possible delays
Number of Treatment-related Toxicities Experienced by Participants
Time frame: Up to week 12
Recurrence-free Survival (RFS)
Time frame: Up to 2 years
Overall Survival (OS)
Time frame: Up to 2 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- UW Carbone Cancer Center home pageLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kari Wisinski, MD principal investigator
University of Wisconsin, Madison
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Carboplatin, Paclitaxel and Doxorubicin in people with Breast Cancer and Triple Negative Breast Cancer, run by University of Wisconsin, Madison at 6 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 19 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 1 Feb 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number and Percentage of Participants With Pathologic Complete Response (pCR) Rate (time frame: Up to 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2026.