Triple Negative Breast CancerPhase 2NCT04437160
Adjuvant Chemotherapy for Triple Negative Breast Cancer Patients With Residual Disease After Neoadjuvant Chemotherapy
A Phase 2 study testing Epirubicin or Pirarubicin and Cyclophosphamide in people with Triple Negative Breast Cancer, run by Chinese Academy of Medical Sciences at 1 site in China.
Trial summary
This study will evaluate the efficacy and safety of antharcycline-based adjuvant chemotherapy compared with observation in triple negative breast cancer (TNBC) patients with residual invasive disease after platinum and taxanes based neoadjuvant chemotherapy. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Triple Negative Breast Cancer
- What is being tested?
- Epirubicin or Pirarubicin and Cyclophosphamide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 286 participants
- Where
- 1 siteChina
- Study dates
- 1 Feb 2020to Dec 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with histologically confirmed invasive adenocarcinoma of the breast.
- Triple negative breast cancer: hormone receptor negative (ER < 10% and PgR < 10%) and HER2 negative (IHC 0/1+ or ISH non-amplified), as defined by the local pathology laboratory.
- Clinical stage at presentation: T1-4, N0-3, M0, with indications for neoadjuvant chemotherapy.
- Patient must have received platinum and taxanes neoadjuvant chemotherapy for at least 4 cycles and no tumor progression occurred.
- Patients should have undergone adequate tumor excision in the breast and lymph nodes after neoadjuvant chemotherapy.
- Residual invasive disease must be ≥1cm in the breast, and/or have positive axillary lymph nodes observed on pathologic exam after neoadjuvant chemotherapy.
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- ECOG Performance Status: 0-1.
- Patients without severe heart, lung, liver and kidney disease.
- Adequate hematologic and end-organ function.
- No more than 6 weeks may elapse between definitive breast surgery and randomization.
Who cannot join
- Previous neoadjuvant chemotherapy with anthracycline or other drugs (except platinum and taxanes).
- Previous neoadjuvant chemotherapy with platinum or taxanes alone.
- Patients have received other adjuvant therapy.
- Comprehensive medical examinations have revealed distant metastases before randomization.
- Patients who are not suitable for anthracycline evaluated by investigators.
- Prior history of other malignancy (except carcinoma in situ).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Cancer Hospital & Institute Chinese Academy of Medical Sciences (CAMS)
Beijing, Beijing Municipality, 100021
Pin ZHANG, MD, 13701275563, Zhang_pin@sina.com
About this study
Official title: A Multicenter, Randomised, Open-label Phase II Study to Evaluate the Efficacy and Safety of Adjuvant Chemotherapy for Triple Negative Breast Cancer Patients With Residual Disease After Platinum-based Neoadjuvant Chemotherapy
This study will evaluate the efficacy and safety of antharcycline-based adjuvant chemotherapy compared with observation in triple negative breast cancer (TNBC) patients with residual invasive disease after platinum and taxanes based neoadjuvant chemotherapy.
Read the detailed description
This study is a multi-center, randomized, phase II study. TNBC patients with residual invasive disease (invasive breast tumor size≥1cm and/or positive axillary lymph nodes) after platinum and taxanes based neoadjuvant chemotherapy are enrolled (n = 286). Patients are assigned to the chemotherapy group or the observation group at a 1:1 ratio randomly 4-6 weeks after surgery. Patients in the chemotherapy group are given anthracycline combined with cyclophosphamide regimen for 4 cycles. At the same time, the blood and tissue samples are collected for relevant tests. Follow up every 3-6 months and record recurrences and deaths.
- Conditions
- Triple Negative Breast Cancer
- Being tested
- Epirubicin or Pirarubicin, Cyclophosphamide
- Keywords
- Triple negative breast cancer, Neoadjuvant chemotherapy, Residual invasive breast cancer, Adjuvant chemotherapy
- Medical subject headings
- Triple Negative Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Epirubicin or PirarubicinDrug
Also called EPI or THP
Epirubicin 80-90mg/m2 IV or Pirarubicin 50mg/m2 IV, q21d*4cycls
CyclophosphamideDrug
Also called CTX
Cyclophosphamide 600mg/m2 IV, q21d*4cycls
| Study group | Role | What they receive |
|---|---|---|
| Adjuvant chemotherapy | Experimental | Adjuvant chemotherapy for triple negative breast cancer with residual invasive disease (invasive breast tumor size≥1cm and/or positive axillary lymph nodes) after taxanes and platinum based neoadjuvant chemotherapy.
Adjuvant chemotherapy regiments: Epirubicin 80-90mg/m2 IV or Pirarubicin 50mg/m2 IV + Cyclophosphamide 600mg/m2 IV, q21d*4cycles. Receives: Drug: Epirubicin or Pirarubicin; Drug: Cyclophosphamide |
| Observation | No intervention | No adjuvant chemotherapy for triple negative breast cancer with residual invasive disease (invasive breast tumor size≥1cm and/or positive axillary lymph nodes) after taxanes and platinum based neoadjuvant chemotherapy. |
What is being measured
The primary outcome is the main question the study is designed to answer.
RFS
RFS defined as the time from randomization to the first recurrence event or death through the end of study
Measured: median 5 years
Secondary outcomes (3)
OS
OS defined as the time from randomization to all-cause death through the end of study
Measured: median 5 years
Percentage of patients with adverse events
To assess the toxicity of adjuvant chemotherapy by CTCAE v5.0
Measured: 2-3 years
Changes in patient-reported quality of life
To assess the mean changes from baseline score in patient-reported quality of life using EORTC QLQ-C30
Measured: 2-3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2020
- Study start1 Feb 2020
- Primary completionJan 2026 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Triple Negative 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 286 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese Academy of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pin Zhang, Chinese Academy of Medical Sciences
- Investigators
- Pin ZHANG, MD, Principal investigator, Chinese Academy of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04437160
- Sponsor's protocol ID
- LC2019L06
- Status last verified
- Jun 2020
- First submitted
- 5 Jun 2020
- Last updated
- 18 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomised, Open-label Phase II Study to Evaluate the Efficacy and Safety of Adjuvant Chemotherapy for Triple Negative Breast Cancer Patients With Residual Disease After Platinum-based Neoadjuvant Chemotherapy
- ClinicalTrials.gov ID
- NCT04437160
- Acronym / sponsor ID
- LC2019L06
- Conditions
- Triple Negative Breast Cancer
- Keywords
- Triple negative breast cancer, Neoadjuvant chemotherapy, Residual invasive breast cancer, Adjuvant chemotherapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 286 participants (estimated)
- Lead sponsor
- Chinese Academy of Medical SciencesUniversity, hospital or other
- Study start
- 1 Feb 2020 (actual)
- Primary completion
- Jan 2026 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 18 Jun 2020 (actual)
- 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 will evaluate the efficacy and safety of antharcycline-based adjuvant chemotherapy compared with observation in triple negative breast cancer (TNBC) patients with residual invasive disease after platinum and taxanes based neoadjuvant chemotherapy.
Detailed description
This study is a multi-center, randomized, phase II study. TNBC patients with residual invasive disease (invasive breast tumor size≥1cm and/or positive axillary lymph nodes) after platinum and taxanes based neoadjuvant chemotherapy are enrolled (n = 286). Patients are assigned to the chemotherapy group or the observation group at a 1:1 ratio randomly 4-6 weeks after surgery. Patients in the chemotherapy group are given anthracycline combined with cyclophosphamide regimen for 4 cycles. At the same time, the blood and tissue samples are collected for relevant tests. Follow up every 3-6 months and record recurrences and deaths.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Adjuvant chemotherapy | Experimental | Drug: Epirubicin or Pirarubicin, Drug: CyclophosphamideAdjuvant chemotherapy for triple negative breast cancer with residual invasive disease (invasive breast tumor size≥1cm and/or positive axillary lymph nodes) after taxanes and platinum based neoadjuvant chemotherapy. Adjuvant chemotherapy regiments: Epirubicin 80-90mg/m2 IV or Pirarubicin 50mg/m2 IV + Cyclophosphamide 600mg/m2 IV, q21d*4cycles. |
| Observation | No intervention | –No adjuvant chemotherapy for triple negative breast cancer with residual invasive disease (invasive breast tumor size≥1cm and/or positive axillary lymph nodes) after taxanes and platinum based neoadjuvant chemotherapy. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Patients with histologically confirmed invasive adenocarcinoma of the breast.
- Triple negative breast cancer: hormone receptor negative (ER < 10% and PgR < 10%) and HER2 negative (IHC 0/1+ or ISH non-amplified), as defined by the local pathology laboratory.
- Clinical stage at presentation: T1-4, N0-3, M0, with indications for neoadjuvant chemotherapy.
- Patient must have received platinum and taxanes neoadjuvant chemotherapy for at least 4 cycles and no tumor progression occurred.
- Patients should have undergone adequate tumor excision in the breast and lymph nodes after neoadjuvant chemotherapy.
Key exclusion criteria (6 listed)
- Previous neoadjuvant chemotherapy with anthracycline or other drugs (except platinum and taxanes).
- Previous neoadjuvant chemotherapy with platinum or taxanes alone.
- Patients have received other adjuvant therapy.
- Comprehensive medical examinations have revealed distant metastases before randomization.
- Patients who are not suitable for anthracycline evaluated by investigators.
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 |
|---|---|---|
| Epirubicin or PirarubicinAlso: EPI or THPEpirubicin 80-90mg/m2 IV or Pirarubicin 50mg/m2 IV, q21d*4cycls | Drug | Adjuvant chemotherapy |
| CyclophosphamideAlso: CTXCyclophosphamide 600mg/m2 IV, q21d*4cycls | Drug | Adjuvant chemotherapy |
Primary outcome
RFS
Time frame: median 5 years
RFS defined as the time from randomization to the first recurrence event or death through the end of study
3 secondary outcomes
OS
Time frame: median 5 years
Percentage of patients with adverse events
Time frame: 2-3 years
Changes in patient-reported quality of life
Time frame: 2-3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2020.
- 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.
Pin ZHANG, MD principal investigator
Chinese Academy of Medical Sciences
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 Epirubicin or Pirarubicin and Cyclophosphamide in people with Triple Negative Breast Cancer, run by Chinese Academy of Medical Sciences 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 10 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 18 Jun 2020. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Pin ZHANG, MD (008601-87788120, Zhang_pin@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
RFS (time frame: median 5 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 18 Jun 2020.