Breast CancerPhase 2CADENCENCT02547987
Neoadjuvant Carboplatin and Docetaxel in Triple Negative Breast Cancer
A Phase 2 study testing Docetaxel and Carboplatin in people with Breast Cancer, run by Mothaffar Rimawi at 3 sites in United States.
Trial summary
The purpose of this study is to determine whether the combination of docetaxel and carboplatin is an effective treatment for patients with triple negative breast cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Docetaxel and Carboplatin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 3 sitesUnited States
- Study dates
- 1 Nov 2015to Sep 2025
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All patients must be 18 years of age or older.
- All patients must be diagnosed with invasive breast cancer.
- Breast cancer must be ER-negative, and HER-2 negative according to CAP/ASCO biomarkers testing guidelines. Tumors may be PgR positive with an Allred score of less than 5.
- Primary breast tumor size at least 2 cm in one dimension by clinical or radiographic exam. Patients who have multicentric breast cancer are eligible if each lesion is estrogen receptor negative and HER2-negative. In that case, one lesion needs to be identified as the index lesion to be followed for clinical response. The index lesion must also be the lesion from which core biopsies are obtained.
- Patients with inflammatory breast cancer are eligible if they meet both of the following criteria:
- Patient has an underlying, clinically palpable breast mass of at least 2cm, AND
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- a corresponding lesion is visualized on mammogram or ultrasound
- Normal bone marrow and organ function as defined below:
- Leukocytes > 3,000/mcL
- Absolute neutrophil count > 1,200/mcl
- Platelets > 100,000/mcl
- Serum bilirubin ≤ institutional 1.5 times upper limit of normal (ULN)
- Aspartate aminotransferase/alanine aminotransferase ≤ 2.5 times ULN
- Creatinine ≤ 1.5 ULN
- Women of childbearing potential (defined as women under the age of 55 with intact ovaries and uterus) must agree to use adequate contraception prior to study entry and for the duration of study participation. They must also have a negative urine pregnancy test within 7 days of starting treatment.
- Ability to understand and willingness to sign an IRB approved written informed consent document and follow study procedures including willingness to undergo study biopsies.
Who cannot join
- Any prior systemic therapy for breast cancer within 5 years.
- A history of other malignancy ≤ 5 years previous with the exception of basal cell or squamous cell carcinoma of the skin which were treated with local resection only or carcinoma in situ of the cervix.
- Patients with known bilateral invasive breast cancer. Patients with contralateral in situ breast carcinoma are eligible.
- Inflammatory breast cancer.
- Patients with confirmed stage IV disease.
- Currently receiving any other investigational agents.
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- A history of allergic reactions attributed to compounds of similar chemical or biologic composition to docetaxel or carboplatin.
- Known to be seropositive for human immunodeficiency virus (HIV), hepatitis C virus (HCV), or hepatitis B virus (HBV).
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
- If the patient is otherwise not deemed a good study candidate by sole discretion of the principal investigator.
- Patient is pregnant or breastfeeding.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
TriHealth Hatton Research
Cincinnati, Ohio, 45242
Lester & Sue Smith Breast Center at Baylor College of Medicine
Houston, Texas, 77030
Harris Health System Smith Clinic
Houston, Texas, 77054
About this study
Official title: CADENCE: Carboplatin and Docetaxel in Neoadjuvant Treatment of ER-Negative, HER2-Negative Breast Cancer: A Co-Clinical Trial With Genoproteomic Discovery
The purpose of this study is to determine whether the combination of docetaxel and carboplatin is an effective treatment for patients with triple negative breast cancer.
Read the detailed description
PRIMARY OBJECTIVE:
To determine whether neoadjuvant docetaxel and carboplatin will increase the pCR rate in TNBC compared to historical controls. Pathologic complete response (pCR) will be defined as no residual invasive breast cancer in the breast and ipsilateral axillary lymph node (ypT0-is ypN0).
- Conditions
- Breast Cancer
- Being tested
- Docetaxel, Carboplatin
- Keywords
- breast cancer, triple negative, TNBC, triple negative breast cancer
- 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.
DocetaxelDrug
Also called Taxotere
Docetaxel 75 mg/m2 intravenously on day 1 of each 21-day cycle. Number of Cycles: 6
CarboplatinDrug
Also called Paraplatin
Carboplatin AUC 6 intravenously on day 1 of each 21-day cycle. Number of Cycles: 6
| Study group | Role | What they receive |
|---|---|---|
| Docetaxel/Carboplatin | Experimental | Docetaxel 75 mg/m2 plus Carboplatin AUC 6 IV on Day 1 of each 21 day cycle for 6 cycles Receives: Drug: Docetaxel; Drug: Carboplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pathologic Complete Response
This is the complete disappearance of invasive cancer in the breast at the time of surgery
Measured: At the time of definitive surgery (approximately 4-5 months after beginning chemotherapy)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2015 (estimated)
- Study start1 Nov 2015
- Primary completion25 Jun 2019
- Study completionSep 2025 (estimated)
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- 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
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mothaffar Rimawi
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Mothaffar Rimawi, Baylor Breast Care Center
- Investigators
- Mothaffar Rimawi, MD, Principal investigator, Baylor College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02547987
- Sponsor's protocol ID
- H- 36960 CADENCE
- Acronym
- CADENCE
- Status last verified
- Feb 2025
- First submitted
- 10 Sep 2015
- Last updated
- 12 Mar 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Ademuyiwa FO, Chen I, Luo J, Rimawi MF, Hagemann IS, Fisk B, Jeffers G, Skidmore ZL, Basu A, Richters M, Ma CX, Weilbaecher K, Davis J, Suresh R, Peterson LL, Bose R, Bagegni N, Rigden CE, Frith A, Rearden TP, Hernandez-Aya LF, Roshal A, Clifton K, Opyrchal M, Akintola-Ogunremi O, Lee BH, Ferrando-Martinez S, Church SE, Anurag M, Ellis MJ, Gao F, Gillanders W, Griffith OL, Griffith M. Immunogenomic profiling and pathological response results from a clinical trial of docetaxel and carboplatin in triple-negative breast cancer. Breast Cancer Res Treat. 2021 Aug;189(1):187-202. doi: 10.1007/s10549-021-06307-3. Epub 2021 Jun 26.
PubMed 34173924
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CADENCE: Carboplatin and Docetaxel in Neoadjuvant Treatment of ER-Negative, HER2-Negative Breast Cancer: A Co-Clinical Trial With Genoproteomic Discovery
- ClinicalTrials.gov ID
- NCT02547987
- Acronym / sponsor ID
- CADENCE / H- 36960 CADENCE
- Conditions
- Breast Cancer
- Keywords
- breast cancer, triple negative, TNBC, triple negative breast cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Mothaffar RimawiUniversity, hospital or other
- Study start
- 1 Nov 2015 (actual)
- Primary completion
- 25 Jun 2019 (actual)
- Study completion
- Sep 2025 (estimated)
- First posted
- 14 Sep 2015 (estimated)
- Results
- Posted 13 Nov 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine whether the combination of docetaxel and carboplatin is an effective treatment for patients with triple negative breast cancer.
Detailed description
PRIMARY OBJECTIVE:
To determine whether neoadjuvant docetaxel and carboplatin will increase the pCR rate in TNBC compared to historical controls. Pathologic complete response (pCR) will be defined as no residual invasive breast cancer in the breast and ipsilateral axillary lymph node (ypT0-is ypN0).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Docetaxel/Carboplatin | Experimental | Drug: Docetaxel, Drug: CarboplatinDocetaxel 75 mg/m2 plus Carboplatin AUC 6 IV on Day 1 of each 21 day cycle for 6 cycles |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- All patients must be 18 years of age or older.
- All patients must be diagnosed with invasive breast cancer.
- Breast cancer must be ER-negative, and HER-2 negative according to CAP/ASCO biomarkers testing guidelines. Tumors may be PgR positive with an Allred score of less than 5.
- Primary breast tumor size at least 2 cm in one dimension by clinical or radiographic exam. Patients who have multicentric breast cancer are eligible if each lesion is estrogen receptor negative and HER2-negative. In that case, one lesion needs to be identified as the index lesion to be followed for clinical response. The index lesion must also be the lesion from which core biopsies are obtained.
- Patients with inflammatory breast cancer are eligible if they meet both of the following criteria:
Key exclusion criteria (11 listed)
- Any prior systemic therapy for breast cancer within 5 years.
- A history of other malignancy ≤ 5 years previous with the exception of basal cell or squamous cell carcinoma of the skin which were treated with local resection only or carcinoma in situ of the cervix.
- Patients with known bilateral invasive breast cancer. Patients with contralateral in situ breast carcinoma are eligible.
- Inflammatory breast cancer.
- Patients with confirmed stage IV disease.
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 |
|---|---|---|
| DocetaxelAlso: TaxotereDocetaxel 75 mg/m2 intravenously on day 1 of each 21-day cycle. Number of Cycles: 6 | Drug | Docetaxel/Carboplatin |
| CarboplatinAlso: ParaplatinCarboplatin AUC 6 intravenously on day 1 of each 21-day cycle. Number of Cycles: 6 | Drug | Docetaxel/Carboplatin |
Primary outcome
Pathologic Complete Response
Time frame: At the time of definitive surgery (approximately 4-5 months after beginning chemotherapy)
This is the complete disappearance of invasive cancer in the breast at the time of surgery
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 34173924Ademuyiwa FO, Chen I, Luo J, Rimawi MF, Hagemann IS, Fisk B, Jeffers G, Skidmore ZL, Basu A, Richters M, Ma CX, Weilbaecher K, Davis J, Suresh R, Peterson LL, Bose R, Bagegni N, Rigden CE, Frith A, Rearden TP, Hernandez-Aya LF, Roshal A, Clifton K, Opyrchal M, Akintola-Ogunremi O, Lee BH, Ferrando-Martinez S, Church SE, Anurag M, Ellis MJ, Gao F, Gillanders W, Griffith OL, Griffith M. Immunogenomic profiling and pathological response results from a clinical trial of docetaxel and carboplatin in triple-negative breast cancer. Breast Cancer Res Treat. 2021 Aug;189(1):187-202. doi: 10.1007/s10549-021-06307-3. Epub 2021 Jun 26.
- Individual participant dataSharing planned: No
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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.
Mothaffar Rimawi, MD principal investigator
Baylor College of Medicine
3 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 Docetaxel and Carboplatin in people with Breast Cancer, run by Mothaffar Rimawi at 3 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 16 inclusion and 11 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: under way, not looking for participants, as of the sponsor's last update on 12 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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 13 Nov 2019). 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?
Pathologic Complete Response (time frame: At the time of definitive surgery (approximately 4-5 months after beginning chemotherapy)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02547987, which also lists 1 linked publication.
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 12 Mar 2025.