Breast CancerPhase 3NCT01752686
A Phase III Trial of Carboplatin as Adjuvant Chemotherapy in Triple Negative Breast Cancer
A Phase 3 study testing carboplatin in people with Breast Cancer, run by Severance Hospital.
Trial summary
This study is designed to investigate the efficacy of carboplatin, as a post-operative adjuvant chemotherapy for triple negative breast cancer patients who have pathologic residual cancer after the preoperative chemotherapy. Read more about this study
- Who is it for?
- Ages 20 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- carboplatin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 587 participants
- Where
- No sites listed yet
- Study dates
- Mar 2013to Mar 2018
- Phase
- Phase 3
- 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 20 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of breast cancer
- Female patients
- Histologically confirmed invasive breast cancer
- Primary tumor greater than 2cm diameter, measured by mammography and sonography
- Any N
- ER (estrogen receptor)/ PR (progesterone receptor) / HER2 (negative/ negative/ negative)(ER <1%, PR<1%, IHC 0, 1+ or FISH - in case of IHC (immuno-histochemistry) 2+)
Show all 17Show fewer
- No evidence of metastasis (M0)
- No prior hormonal, chemotherapy or radiotherapy is allowed.
- No breast operation other than biopsy to make diagnosis is allowed.
- Age: 20-years and older, not pregnant pre-, and postmenopausal women with good performance status (ECOG 0-1)
- Adequate hematopoietic function: Absolute granulocyte count 1500/mm3, platelet 100,000/mm3, Hemoglobin 10 g/mm3
- Adequate renal function: Serum creatinine 1.5 mg/dl
- Adequate hepatic function: total bilirubin: 1.5 mg/dl, AST(aspartate aminotransferase)/ALT (alanine transaminase): 2 times normal, Alkaline phosphatase:2 times normal
- Written informed consent
- Normal mental function to understand and sign the consent
- Cardiac function: normal or nonspecific EKG taken within 1 mo of enrollment.
- LVEF (left ventricular ejection fraction)50% by MUGA (multiple gated acquisition scan) or Echocardiogram taken within 1 mo of enrollment
Who cannot join
- Patients who received hormonal, chemotherapy or radiotherapy for breast cancer
- Patients who underwent surgery for breast cancer
- Patients with a history of uncompensated congestive heart failure
- Patients with inflammatory breast cancer (T4d)
- Patients without primary tumor (T0)
- Patients who have history of cancer other than in situ uterine cervix cancer or non-melanotic skin cancer
- Known hypersensitivity to any of the study drugs
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Phase III Trial of Carboplatin as Adjuvant Chemotherapy Versus Observation in Triple Negative Breast Cancer With Pathologic Residual Cancer After Neoadjuvant Chemotherapy: POST-Neo Adjuvant Study
This study is designed to investigate the efficacy of carboplatin, as a post-operative adjuvant chemotherapy for triple negative breast cancer patients who have pathologic residual cancer after the preoperative chemotherapy.
Read the detailed description
In Neo-adjuvant period Four cycles of 60 mg/m2 doxorubicin and 600 mg/m2 cyclophosphamide therapy at 3-week intervals followed by four cycles of 100 mg/m2 docetaxel at 3-week intervals.
In POST Neo-adjuvant period
Randomization:
At the time of post neo-adjuvant period, the patients will be assigned to each treatment group in a 1:1 ratio i.e. carboplatin AUC 6 group vs. observation group. Six cycles of carboplatin (AUC=6) on the first day of every 21 days.
- Conditions
- Breast Cancer
- Being tested
- carboplatin
- Keywords
- Triple negative breast cancer, adjuvant chemotherapy
- 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
Also called Adding adjuvant arm
carboplatin as adjuvant chemotherapy
| Study group | Role | What they receive |
|---|---|---|
| carboplatin chemotherapy | Experimental | At the time of post neo-adjuvant period, the patients will be assigned to each treatment group in a 1:1 ratio i.e. carboplatin AUC 6 group vs. observation group. Six cycles of carboplatin (AUC=6) on the first day of every 21 days. Receives: Drug: carboplatin |
| Observation arm | No intervention | In this observation arm, patients should be follow up with regular interval without treatment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease-free survival (DFS)
To compare DFS between carboplatin and observation within non-pCR (complete remission) patients
Measured: up to 3 years
Secondary outcomes (4)
overall survival
To compare overall survival (OS) between carboplatin and observation within non-pCR patients.
Measured: up to 5years
pCR rate
To assess the pCR rate (no residual invasive carcinoma in primary breast and axillary lymph node) within total TNBC patients.
Measured: up to 3 years
The percentage of patients who receive breast conserving surgery.
To assess the percentage of patients who receive breast conserving surgery within total triple negative breast cancer patients
Measured: up to 3years
Number of adverse events
Number of adverse events in patients with non-pCR.
Measured: up to 3years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2012 (estimated)
- Study startMar 2013
- Primary completionMar 2017 (estimated)
- Study completionMar 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 587 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Severance Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Byeong Woo Park, Severance Hospital
- Investigators
- Byeong Woo Park, MD, PhD, Principal investigator, Severance Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01752686
- Sponsor's protocol ID
- Severance_BR_01
- Other IDs
- DA-TNBC
- Status last verified
- Dec 2012
- First submitted
- 26 Sep 2012
- Last updated
- 25 Dec 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III Trial of Carboplatin as Adjuvant Chemotherapy Versus Observation in Triple Negative Breast Cancer With Pathologic Residual Cancer After Neoadjuvant Chemotherapy: POST-Neo Adjuvant Study
- ClinicalTrials.gov ID
- NCT01752686
- Acronym / sponsor ID
- Severance_BR_01
- Conditions
- Breast Cancer
- Keywords
- Triple negative breast cancer, adjuvant chemotherapy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 587 participants (estimated)
- Lead sponsor
- Severance HospitalUniversity, hospital or other
- Study start
- Mar 2013
- Primary completion
- Mar 2017 (estimated)
- Study completion
- Mar 2018 (estimated)
- First posted
- 19 Dec 2012 (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.
This study is designed to investigate the efficacy of carboplatin, as a post-operative adjuvant chemotherapy for triple negative breast cancer patients who have pathologic residual cancer after the preoperative chemotherapy.
Detailed description
In Neo-adjuvant period Four cycles of 60 mg/m2 doxorubicin and 600 mg/m2 cyclophosphamide therapy at 3-week intervals followed by four cycles of 100 mg/m2 docetaxel at 3-week intervals.
In POST Neo-adjuvant period
Randomization:
At the time of post neo-adjuvant period, the patients will be assigned to each treatment group in a 1:1 ratio i.e. carboplatin AUC 6 group vs. observation group. Six cycles of carboplatin (AUC=6) on the first day of every 21 days.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| carboplatin chemotherapy | Experimental | Drug: carboplatinAt the time of post neo-adjuvant period, the patients will be assigned to each treatment group in a 1:1 ratio i.e. carboplatin AUC 6 group vs. observation group. Six cycles of carboplatin (AUC=6) on the first day of every 21 days. |
| Observation arm | No intervention | –In this observation arm, patients should be follow up with regular interval without treatment. |
Who may qualify
- Ages
- 20 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Clinical diagnosis of breast cancer
Key exclusion criteria (7 listed)
- Patients who received hormonal, chemotherapy or radiotherapy for breast cancer
- Patients who underwent surgery for breast cancer
- Patients with a history of uncompensated congestive heart failure
- Patients with inflammatory breast cancer (T4d)
- Patients without primary tumor (T0)
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 |
|---|---|---|
| carboplatinAlso: Adding adjuvant armcarboplatin as adjuvant chemotherapy | Drug | carboplatin chemotherapy |
Primary outcome
Disease-free survival (DFS)
Time frame: up to 3 years
To compare DFS between carboplatin and observation within non-pCR (complete remission) patients
4 secondary outcomes
overall survival
Time frame: up to 5years
pCR rate
Time frame: up to 3 years
The percentage of patients who receive breast conserving surgery.
Time frame: up to 3years
Number of adverse events
Time frame: up to 3years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Dec 2012.
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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.
Byeong Woo Park, MD, PhD principal investigator
Severance Hospital
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing carboplatin in people with Breast Cancer, run by Severance Hospital.
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 17 inclusion and 7 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 25 Dec 2012. Status can change between updates, so confirm with the study contact before making plans.
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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 Byeong Woo Park, MD, PhD (82-2-2228-8125, nobelg@yuhs.ac), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disease-free survival (DFS) (time frame: up to 3 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 25 Dec 2012.