Breast CancerPhase 3NCT02441933
Carboplatin in EARLY Triple Negative Breast Cancer Trial (PEARLY Trial)
A Phase 3 study testing taxane plus carboplatin and Taxane in people with Breast Cancer, run by Yonsei University at 21 sites in South Korea.
Trial summary
This is a randomized, open-label, multicenter, phase III study comparing anthracyclines followed by taxane to anthracyclines followed by taxane plus carboplatin as (neo)adjuvant therapy in patients with triple-negative breast cancer. Patients with stage II/III operable triple-negative breast cancer are eligible. Read more about this study
- Who is it for?
- Ages 19 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- taxane plus carboplatin and Taxane
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 878 participants
- Where
- 21 sitesSouth Korea
- Study dates
- 1 Sep 2015to 30 Jun 2025
- 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 19 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female patients who are >18 years of age
- ECOG 0 or 1
- The tumor must be invasive carcinoma of the breast on histologic examination
- The tumor must have been determined to be HER2-negative, as follows:
- IHC 0 or 1+; or
- IHC 2+ and ISH non-amplified, with a ratio of <2.0, and if reported, an average HER2 gene copy number of <6 signals/cell; or
Show all 20Show fewer
- ISH non-amplified without IHC
- The tumor must have been determined to be ER- and PR-negative, as assessed by the current ASCO/CAP guidelines.
- All of the following staging criteria (AJCC 7th edition) must be met:
- Lymph node-positive disease: cytologically positive in the neoadjuvant group* and pathologically positive in the adjuvant group
- If the lymph node is cytologically or pathologically negative, the tumor size must be >2.0 cm (* In the neoadjuvant group, if there is evidence of suspicious axillary lymph nodes at the baseline imaging study or physical examination, then FNA or core biopsy is required to confirm the nodal status)
- The patient must have undergone either a mastectomy or lumpectomy in the adjuvant group
- The patient must have completed one of the nodal surgery procedures listed below in the adjuvant group:
- Sentinel lymph node biopsy (SLNB) alone:
- V If pathologic nodal staging based on SLNB is pN0 V If pathologic nodal staging based on SLNB is 1 or 2 positive nodes, the primary tumor must be T1 or T2 by pathologic evaluation and lumpectomy and the nodal involvement must be limited to 1 or 2 positive nodes
- SLNB followed by removal of additional non-sentinel LNs if the SLN is positive; or
- Axillary lymphadenectomy with or without SLNB (In the neoadjuvant group, if baseline LN NAB or core biopsy is positive, ALND should be performed) 9) LVEF assessment by echocardiography or MUGA scan must be >50%, regardless of the cardiac imaging facility's lower limit of normal 10) The patient must have adequate hepatic, renal, and bone marrow function;
- Bone marrow function Hb: ≥ 10.0 g/dL ANC: ≥ 1,500/µL Platelet count: ≥ 10 × 10⁴/µL
- Renal function Creatinine: ≤ 1.5 × UNL or Creatine clearance (Ccr) >50 ml/min by the Cockcroft formula
- Hepatic function Total Bilirubin: ≤ 1.5 × UNL AST/ALT: ≤ 2.5 × UNL 10) Ability and willingness to comply with the study visits, treatment, testing, and with the protocol, as per investigator's judgment
Who cannot join
- Any prior systemic treatment for primary invasive breast cancer
- cT4 or pT4 tumors including inflammatory breast cancer
- Occult breast cancer
- Evidence of metastatic breast cancer
- Patients with second primary cancer; EXCEPTIONS: adequately treated non-melanoma skin cancer, curatively treated in situ cancer of the cervix, DCIS of the breast, thyroid cancer with a size of <2 cm (papillary, follicular, and medullary type), and other solid tumors curatively treated with no evidence of disease for >5 years prior to randomization.
- Simultaneous bilateral breast cancer
- Patients considered a poor medical risk due to a serious, uncontrolled medical disorder or uncontrolled infection.
- Pregnant or breastfeeding women
Trial locations and contacts
21 sites in 1 country.
21 sites in 1 country
South Korea21 sites
Inje University Haeundae Paik Hospital
Busan
Soonchunhyang university Cheonan hospital
Cheonan, Gyungkido
Chungbuk university hospital
Cheonju, Chungchung Do
Keimyung University Dongsan Medical Center
Daegu
National Cancer Center
Goyang, Gyeonggido
National Health Insurance Service Ilsan Hospital
Ilsan, Gyeonggido
Gachon University Gil Medical Center
Incheon
Bundang Cha Hospital
Seongnam, Gyeonggido
Seoul national university Bundang Hospital
Seongnam
Asan Medical Center
Seoul
Boramae Medical Center
Seoul
Catholic university of Korea, Seoul St. Mary's Hospital
Seoul
Chung Ang University Heaelthcare System
Seoul
Gangnam Severance hospital
Seoul
Korea University Anam hospital
Seoul
Kyunghee University Healthcare System
Seoul
Samsung Medical Center
Seoul
Yonsei Cancer Center at Yonsei University Medical Center
Seoul
Ajou universwity Medical Center
Suwon, Gyeonggido
Ulsan University Hospital
Ulsan
Wonju Severance Christian Hospital
Wŏnju
About this study
Official title: A Randomized, Multicenter, Open-label, Phase III Trial Comparing Anthracyclines Followed by Taxane Versus Anthracyclines Followed by Taxane Plus Carboplatin as (Neo) Adjuvant Therapy in Patients With Triple-negative Breast Cancer
This is a randomized, open-label, multicenter, phase III study comparing anthracyclines followed by taxane to anthracyclines followed by taxane plus carboplatin as (neo)adjuvant therapy in patients with triple-negative breast cancer.
Patients with stage II/III operable triple-negative breast cancer are eligible. Patients who need adjuvant chemotherapy after breast surgery as well as patients who need neoadjuvant chemotherapy for TNBC are eligible.
- Conditions
- Breast Cancer
- Being tested
- taxane plus carboplatin, Taxane
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
taxane plus carboplatinDrug
Doxorubicin (60 mg/m2) IV + cyclophosphamide (600 mg/m2) IV every 3 weeks for 4 cycles followed by taxane plus carboplatin for 4 cycles The taxane plus carboplatin regimen can be selected based on the investigator's discretion from among the following two regimens.
- Docetaxel (75 mg/m2) IV plus carboplatin (AUC 5) IV every 3 weeks for 4 cycles
- Paclitaxel (80 mg/m2) IV weekly for 12 doses plus carboplatin (AUC 5) IV every 3 weeks for 4 cycles
TaxaneDrug
Doxorubicin (60 mg/m2) IV + cyclophosphamide (600 mg/m2) IV every 3 weeks for 4 cycles followed by taxane for 4 cycles The taxane regimen can be selected at the investigator's discretion from among the following two regimens.
- Docetaxel (75 mg/m2) IV every 3 weeks for 4 cycles
- Paclitaxel (80 mg/m2) IV weekly for 12 doses
| Study group | Role | What they receive |
|---|---|---|
| control group | Active comparator | Not described Receives: Drug: Taxane |
| carboplatin group | Experimental | Not described Receives: Drug: taxane plus carboplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
5-year event-free survival (EFS)
time from Cycle1 Day1 to the occurrence of the following events
: loco-regional recurrence, distant recurrence, death from any cause, contralateral invasive breast cancer, second primary cancer, and cancer after surgery (not R0 resection), definitive disease progression during neoadjuvant chemotherapy, inoperable status after neoadjuvant chemotherapy
Measured: 5 year
Secondary outcomes (4)
overall survival
Time from C1D1 until death from any cause
Measured: 5 year
Distant recurrence free survival
Time from C1D1 until distant recurrence
Measured: 5 year
loco-regional recurrence free survival
Time from C1D1 until locoregional recurrence
Measured: 5 year
pathologic complete response rate
no evidence of invasive carcinoma in both breast and axillary lymph nodes, regardless of ductal carcinoma in situ (ypT0isN0)
Measured: 5 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2015 (estimated)
- Study start1 Sep 2015
- Primary completion30 Jun 2025 (estimated)
- Study completion30 Jun 2025 (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 Yonsei UniversityThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 878 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02441933
- Sponsor's protocol ID
- 4-2015-0074
- Status last verified
- May 2024
- First submitted
- 4 May 2015
- Last updated
- 4 Jun 2024
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Kim MH, Kim GM, Ahn JM, Ryu WJ, Kim SG, Kim JH, Kim TY, Han HJ, Kim JY, Park HS, Park S, Park BW, Kim SI, Jeong J, Lee J, Paik S, Kim S, Jung KH, Cho EH, Sohn J. Copy number aberrations in circulating tumor DNA enables prognosis prediction and molecular characterization of breast cancer. J Natl Cancer Inst. 2023 Sep 7;115(9):1036-1049. doi: 10.1093/jnci/djad080.
PubMed 37166557
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Multicenter, Open-label, Phase III Trial Comparing Anthracyclines Followed by Taxane Versus Anthracyclines Followed by Taxane Plus Carboplatin as (Neo) Adjuvant Therapy in Patients With Triple-negative Breast Cancer
- ClinicalTrials.gov ID
- NCT02441933
- Acronym / sponsor ID
- 4-2015-0074
- Conditions
- Breast Cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 878 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- 1 Sep 2015 (actual)
- Primary completion
- 30 Jun 2025 (estimated)
- Study completion
- 30 Jun 2025 (estimated)
- First posted
- 12 May 2015 (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 is a randomized, open-label, multicenter, phase III study comparing anthracyclines followed by taxane to anthracyclines followed by taxane plus carboplatin as (neo)adjuvant therapy in patients with triple-negative breast cancer.
Patients with stage II/III operable triple-negative breast cancer are eligible. Patients who need adjuvant chemotherapy after breast surgery as well as patients who need neoadjuvant chemotherapy for TNBC are eligible.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control group | Active comparator | Drug: Taxane |
| carboplatin group | Experimental | Drug: taxane plus carboplatin |
Who may qualify
- Ages
- 19 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- Female patients who are >18 years of age
- ECOG 0 or 1
- The tumor must be invasive carcinoma of the breast on histologic examination
- The tumor must have been determined to be HER2-negative, as follows:
- The tumor must have been determined to be ER- and PR-negative, as assessed by the current ASCO/CAP guidelines.
Key exclusion criteria (8 listed)
- Any prior systemic treatment for primary invasive breast cancer
- cT4 or pT4 tumors including inflammatory breast cancer
- Occult breast cancer
- Evidence of metastatic breast cancer
- Patients with second primary cancer; EXCEPTIONS: adequately treated non-melanoma skin cancer, curatively treated in situ cancer of the cervix, DCIS of the breast, thyroid cancer with a size of <2 cm (papillary, follicular, and medullary type), and other solid tumors curatively treated with no evidence of disease for >5 years prior to randomization.
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 |
|---|---|---|
| taxane plus carboplatinDoxorubicin (60 mg/m2) IV + cyclophosphamide (600 mg/m2) IV every 3 weeks for 4 cycles followed by taxane plus carboplatin for 4 cycles The taxane plus carboplatin regimen can be selected based on the investigator's discretion from among the following two regimens. * Docetaxel (75 mg/m2) IV plus carboplatin (AUC 5) IV every 3 weeks for 4 cycles * Paclitaxel (80 mg/m2) IV weekly for 12 doses plus carboplatin (AUC 5) IV every 3 weeks for 4 cycles | Drug | carboplatin group |
| TaxaneDoxorubicin (60 mg/m2) IV + cyclophosphamide (600 mg/m2) IV every 3 weeks for 4 cycles followed by taxane for 4 cycles The taxane regimen can be selected at the investigator's discretion from among the following two regimens. * Docetaxel (75 mg/m2) IV every 3 weeks for 4 cycles * Paclitaxel (80 mg/m2) IV weekly for 12 doses | Drug | control group |
Primary outcome
5-year event-free survival (EFS)
Time frame: 5 year
time from Cycle1 Day1 to the occurrence of the following events : loco-regional recurrence, distant recurrence, death from any cause, contralateral invasive breast cancer, second primary cancer, and cancer after surgery (not R0 resection), definitive disease progression during neoadjuvant chemotherapy, inoperable status after neoadjuvant chemotherapy
4 secondary outcomes
overall survival
Time frame: 5 year
Distant recurrence free survival
Time frame: 5 year
loco-regional recurrence free survival
Time frame: 5 year
pathologic complete response rate
Time frame: 5 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2024.
- Derived from this study: PubMed 37166557Kim MH, Kim GM, Ahn JM, Ryu WJ, Kim SG, Kim JH, Kim TY, Han HJ, Kim JY, Park HS, Park S, Park BW, Kim SI, Jeong J, Lee J, Paik S, Kim S, Jung KH, Cho EH, Sohn J. Copy number aberrations in circulating tumor DNA enables prognosis prediction and molecular characterization of breast cancer. J Natl Cancer Inst. 2023 Sep 7;115(9):1036-1049. doi: 10.1093/jnci/djad080.
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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.
The record lists no contact. Use the official record to reach the sponsor.
21 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing taxane plus carboplatin and Taxane in people with Breast Cancer, run by Yonsei University at 21 sites in South Korea.
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 20 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: status not confirmed, as of the sponsor's last update on 4 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 sites in South Korea. 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 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?
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?
5-year event-free survival (EFS) (time frame: 5 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 NCT02441933, 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 4 Jun 2024.