Breast CancerPhase 2NCT02059876
Dose-dense (Biweekly) Carboplatin Plus Paclitaxel With or Without Trastuzumab as Neoadjuvant Treatment for Breast Cancer
A Phase 2 study testing carboplatin and paclitaxel and or without trastuzumab in people with Breast Cancer, run by Guangdong Provincial People's Hospital at 1 site in China.
Trial summary
The purpose of this study is to determine the efficacy and safety of dose-dense(biweekly) carboplatin and paclitaxel ± trastuzumab as neoadjuvant treatment in early breast cancer. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- carboplatin and paclitaxel and or without trastuzumab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- Nov 2013to Dec 2014
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically or cytologically confirmed invasive breast carcinoma
- Clinical stage Ⅱ-ⅢB
- Patients must have measurable disease as defined by palpable lesion with both diameters ≥2cm measurable with caliper and/or a positive mammogram or ultrasound with at least one dimension ≥2cm. Bilateral mammogram and clip placement is required for study entry. Baseline measurements of the indicator lesions must be recorded on the Patient Registration Form. To be valid for baseline, the measurements must have been made within the 14 days if palpable. If not palpable, a mammogram or MRI must be done within 14 days. If palpable, a mammogram or MRI must be done within 2 months prior to study entry. If clinically indicated, xrays and scans must be done within 28 days of study entry.
- Eastern Cooperative Oncology Group(ECOG) performance status 0 to 1 within 14 days of study entry
- Normal (greater than 50%) left ventricular ejection fraction (LVEF) by echocardiography
- Signed informed consent
Show all 14Show fewer
- Adequate organ function within 2 weeks of study entry:
- Absolute neutrophil count >1500/mm3, Hgb >9.0 g/dl and platelet count >100,000/mm3
- Total bilirubin < upper limit of normal
- Creatinine < 1.5 mg/dL or calculated cranial cruciate ligament (CrCL) >50mL/min using the Cockcroft Gault equation
- serum glutamate oxaloacetate transaminase(SGOT)(AST) or serum glutamic oxaloacetic transaminase(SGPT)(ALT) and Alkaline Phosphatase must be within the range allowing for eligibility
- Patients must be over 18 years old.
- Women of childbearing potential must have a negative serum pregnancy test performed within 7 days prior to the start of treatment
- Women of childbearing potential and men must agree to use adequate contraception (barrier method of birth control) prior to study entry and for the duration of study participation.
Who cannot join
- Metastatic disease
- Prior chemotherapy, hormonal therapy, biologic therapy, investigational agent, targeted therapy or radiation therapy for current breast cancer. Patients with history of breast cancer greater than 5 years from initial diagnosis are eligible for the study. Patients may not have received anthracycline-based chemotherapy in the past. Patients with history of ductal carcinoma in situ(DCIS) are eligible if there were treated with surgery alone.
- History of previous or current malignancy at other sites with the exception of adequately treated carcinoma in-situ of the cervix or basal or squamous cell carcinoma of the skin. Patients with a history of other malignancies, who remain disease free for greater than five years are eligible.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Guangdong General Hospital
Guangzhou, Guangdong
Liming Yao, 00862083827812 ext. 20984, 13149395530@163.com
About this study
Official title: A Pilot Study of Dose-dense (Biweekly) Carboplatin Plus Paclitaxel With or Without Trastuzumab as Neoadjuvant Treatment for Breast Cancer
The purpose of this study is to determine the efficacy and safety of dose-dense(biweekly) carboplatin and paclitaxel ± trastuzumab as neoadjuvant treatment in early breast cancer.
Read the detailed description
Dose-dense regimens have been shown to improve outcome when given as adjuvant therapy to patients with breast cancer compared with their three weekly counterparts. It is unknown if dose dense neoadjuvant therapy will improve survival in resectable breast cancer. This study is to evaluate the efficacy and safety of dose-dense(biweekly) carboplatin and paclitaxel ± trastuzumab as neoadjuvant treatment in early breast cancer. The endpoint of pathologic complete response is used as a surrogate marker for survival. Safety and tolerability assessed by number of grade 4 toxicities and hospitalizations.
- Conditions
- Breast Cancer
- Being tested
- carboplatin and paclitaxel and or without trastuzumab
- Keywords
- breast cancer, dose dense, neoadjuvant treatment, pathologic complete response
- Medical subject headings
- Breast Neoplasms, Pathologic Complete Response
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
carboplatin and paclitaxel and or without trastuzumabDrug
Also called paclitaxel (Taxol), trastuzumab (Herceptine)
dose-dense(biweekly) carboplatin and paclitaxel and or without trastuzumab as neoadjuvant treatment in early breast cancer
| Study group | Role | What they receive |
|---|---|---|
| carboplatin and paclitaxel ± trastuzumab | Experimental | dose-dense(biweekly) carboplatin and paclitaxel and or without trastuzumab as neoadjuvant treatment in early breast cancer. Receives: Drug: carboplatin and paclitaxel and or without trastuzumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
pathologic complete response
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2014 (estimated)
- Study startNov 2013
- Primary completionDec 2014 (estimated)
- Study completionDec 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Guangdong Provincial People's HospitalThe 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
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guangdong Provincial People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kun Wang, MD, Principal investigator, Guangdong Provincial People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02059876
- Sponsor's protocol ID
- 20120608
- Status last verified
- Nov 2013
- First submitted
- 7 Feb 2014
- Last updated
- 12 Feb 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Citron ML, Berry DA, Cirrincione C, Hudis C, Winer EP, Gradishar WJ, Davidson NE, Martino S, Livingston R, Ingle JN, Perez EA, Carpenter J, Hurd D, Holland JF, Smith BL, Sartor CI, Leung EH, Abrams J, Schilsky RL, Muss HB, Norton L. Randomized trial of dose-dense versus conventionally scheduled and sequential versus concurrent combination chemotherapy as postoperative adjuvant treatment of node-positive primary breast cancer: first report of Intergroup Trial C9741/Cancer and Leukemia Group B Trial 9741. J Clin Oncol. 2003 Apr 15;21(8):1431-9. doi: 10.1200/JCO.2003.09.081. Epub 2003 Feb 13.
PubMed 12668651
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of Dose-dense (Biweekly) Carboplatin Plus Paclitaxel With or Without Trastuzumab as Neoadjuvant Treatment for Breast Cancer
- ClinicalTrials.gov ID
- NCT02059876
- Acronym / sponsor ID
- 20120608
- Conditions
- Breast Cancer
- Keywords
- breast cancer, dose dense, neoadjuvant treatment, pathologic complete response
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Guangdong Provincial People's HospitalUniversity, hospital or other
- Study start
- Nov 2013
- Primary completion
- Dec 2014 (estimated)
- Study completion
- Dec 2014 (estimated)
- First posted
- 11 Feb 2014 (estimated)
- Results
- Not posted in the source record
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 the efficacy and safety of dose-dense(biweekly) carboplatin and paclitaxel ± trastuzumab as neoadjuvant treatment in early breast cancer.
Detailed description
Dose-dense regimens have been shown to improve outcome when given as adjuvant therapy to patients with breast cancer compared with their three weekly counterparts. It is unknown if dose dense neoadjuvant therapy will improve survival in resectable breast cancer. This study is to evaluate the efficacy and safety of dose-dense(biweekly) carboplatin and paclitaxel ± trastuzumab as neoadjuvant treatment in early breast cancer. The endpoint of pathologic complete response is used as a surrogate marker for survival. Safety and tolerability assessed by number of grade 4 toxicities and hospitalizations.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| carboplatin and paclitaxel ± trastuzumab | Experimental | Drug: carboplatin and paclitaxel and or without trastuzumabdose-dense(biweekly) carboplatin and paclitaxel and or without trastuzumab as neoadjuvant treatment in early breast cancer. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Histologically or cytologically confirmed invasive breast carcinoma
- Clinical stage Ⅱ-ⅢB
- Patients must have measurable disease as defined by palpable lesion with both diameters ≥2cm measurable with caliper and/or a positive mammogram or ultrasound with at least one dimension ≥2cm. Bilateral mammogram and clip placement is required for study entry. Baseline measurements of the indicator lesions must be recorded on the Patient Registration Form. To be valid for baseline, the measurements must have been made within the 14 days if palpable. If not palpable, a mammogram or MRI must be done within 14 days. If palpable, a mammogram or MRI must be done within 2 months prior to study entry. If clinically indicated, xrays and scans must be done within 28 days of study entry.
- Eastern Cooperative Oncology Group(ECOG) performance status 0 to 1 within 14 days of study entry
- Normal (greater than 50%) left ventricular ejection fraction (LVEF) by echocardiography
Key exclusion criteria (3 listed)
- Metastatic disease
- Prior chemotherapy, hormonal therapy, biologic therapy, investigational agent, targeted therapy or radiation therapy for current breast cancer. Patients with history of breast cancer greater than 5 years from initial diagnosis are eligible for the study. Patients may not have received anthracycline-based chemotherapy in the past. Patients with history of ductal carcinoma in situ(DCIS) are eligible if there were treated with surgery alone.
- History of previous or current malignancy at other sites with the exception of adequately treated carcinoma in-situ of the cervix or basal or squamous cell carcinoma of the skin. Patients with a history of other malignancies, who remain disease free for greater than five years are eligible.
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 |
|---|---|---|
| carboplatin and paclitaxel and or without trastuzumabAlso: paclitaxel (Taxol), trastuzumab (Herceptine)dose-dense(biweekly) carboplatin and paclitaxel and or without trastuzumab as neoadjuvant treatment in early breast cancer | Drug | carboplatin and paclitaxel ± trastuzumab |
Primary outcome
pathologic complete response
Time frame: one year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2014.
- Background: PubMed 12668651Citron ML, Berry DA, Cirrincione C, Hudis C, Winer EP, Gradishar WJ, Davidson NE, Martino S, Livingston R, Ingle JN, Perez EA, Carpenter J, Hurd D, Holland JF, Smith BL, Sartor CI, Leung EH, Abrams J, Schilsky RL, Muss HB, Norton L. Randomized trial of dose-dense versus conventionally scheduled and sequential versus concurrent combination chemotherapy as postoperative adjuvant treatment of node-positive primary breast cancer: first report of Intergroup Trial C9741/Cancer and Leukemia Group B Trial 9741. J Clin Oncol. 2003 Apr 15;21(8):1431-9. doi: 10.1200/JCO.2003.09.081. Epub 2003 Feb 13.
Related trials for Breast Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 2
Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort
Invasive Mammary Carcinoma, Metastatic Breast Cancer
Not yet recruitingObservational study
Comparison of Reliability, Time Cost, and Participant Comfort of Lymphedema Assessments in Upper Extremity
Lymphedema, Upper Extremity Lymphedema
RecruitingPhase 3
A Study of Camrelizumab Plus Chemotherapy in Combination With or Without Famitinib as Neoadjuvant Therapy in Participants With Triple Negative Breast Cancer (BCTOP-T-N01)
TNBC - Triple-Negative Breast Cancer
RecruitingPhase 3
Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low Trial
Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8
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.
Kun Wang, MD principal investigator
Guangdong Provincial People's Hospital
1 site 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 and paclitaxel and or without trastuzumab in people with Breast Cancer, run by Guangdong Provincial People's Hospital at 1 site in China.
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 14 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 12 Feb 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kun Wang, MD (00862083827812 ext. 50910, gzwangkun@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pathologic complete response (time frame: one year). 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 NCT02059876, 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 Feb 2014.