Triple Negative Breast CancerPhase 2NCT04664972
Comparison of TP and TAC Regimens in Neoadjuvant Treatment of TNBC
A Phase 2 study testing Docetaxel +doxorubicin+ cyclophosphamide and Docetaxel +Cisplatin in people with Triple Negative Breast Cancer, run by Henan Cancer Hospital at 1 site in China.
Trial summary
Previous studies have shown that TNBC is sensitive to DNA crosslinking-related chemotherapeutic drugs such as platinum. However, there is a lack of large sample prospective clinical data to compare the efficacy of TP and EC-T / TEC regimen in the neoadjuvant chemotherapy of TNBC. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Triple Negative Breast Cancer
- What is being tested?
- Docetaxel +doxorubicin+ cyclophosphamide and Docetaxel +Cisplatin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 212 participants
- Where
- 1 siteChina
- Study dates
- 23 Nov 2018to 26 Nov 2022
- 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 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age: 18-70.
- Clinical stage Ⅱ-Ⅲ.
- triple negative and invasive breast cancer confirmed by histopathology:
- Triple negative breast cancer is defined as:
- negative for ER and PR (IHC nuclear staining < 10%).
- Her-2 negative (IHC 0,1 + without FISH, or IHC 2 + and without FISH amplification).
Show all 18Show fewer
- With clinically measurable focus: Measurable lesions observed on ultrasound, mammography, or magnetic resonance imaging (optional) within the month prior to randomization.
- Organ and bone marrow function tests within 1 month before chemotherapy indicate no contraindications to chemotherapy:
- neutrophils count absolute value ≥ 2.0×109/L
- hemoglobin ≥ 100g/L
- blood platelet ≥ 100×109/L
- total bilirubin < 1.5 ULN (upline of normal value)
- creatinine < 1.5×ULN
- AST/ALT < 1.5×ULN;
- Cardiac ultrasound EF value ≥ 55%.
- Females of childbearing age with negative serum pregnancy test 14 days before randomization.
- ECOG score ≤1.
- Sign informed consent.
Who cannot join
- Evidence of metastatic breast cancer (excluding metastatic breast cancer, a chest CT, abdominal ultrasound, or CT and bone scanning should be performed at any time point before diagnosis and randomization; PET/CT scanning can be used as an alternative imaging examination mean) .
- The patients have received chemotherapy, endocrine therapy, targeted therapy, and radiation therapy for this disease.
- The patient has a second primary malignant tumor, except for:
- Thoroughly treated skin cancer
- Due to severe and uncontrollable other medical diseases, researchers believe the existence of chemotherapy contraindications.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparing TP (Docetaxel + Cisplatin) and TAC (Docetaxel + Doxorubicin + Cyclophosphamide) in Neoadjuvant Therapy for Operable Triple Negative Breast Cancer, A Multicenter, Randomized, Phase II Clinical Trial
Previous studies have shown that TNBC is sensitive to DNA crosslinking-related chemotherapeutic drugs such as platinum. However, there is a lack of large sample prospective clinical data to compare the efficacy of TP and EC-T / TEC regimen in the neoadjuvant chemotherapy of TNBC. Besides, the application of anthracycline drugs is limited to a certain extent due to the cardiotoxicity. Based on the above evidence, the researchers hope to explore a more effective and safer new adjuvant therapy for TNBC.
Read the detailed description
In this study, TNBC patients were randomly divided into experimental group and control group, the ratio of experimental group to control group was 1:1. The experimental group received 6 cycles of neoadjuvant chemotherapy (docetaxel 75 mg / m2 day 1 + cisplatin 25 mg / m2 day 1, 2, 3), 21 days as a cycle. The control group was treated with TAC (docetaxel 75mg / M2 + adriamycin 50mg / M2 + cyclophosphamide 500mg / m2) for 6 cycles, 21 days as a cycle. To compare the efficacy and safety of 6*TP (docetaxel + cisplatin) regimen and traditional 6*TAC (docetaxel + doxorubicin + cyclophosphamide) regimen in neoadjuvant chemotherapy of TNBC.
- Conditions
- Triple Negative Breast Cancer
- Being tested
- Docetaxel +doxorubicin+ cyclophosphamide, Docetaxel +Cisplatin
- 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.
Docetaxel +doxorubicin+ cyclophosphamideDrug
Also called TAC regimen group
The control group was treated with TAC (docetaxel 75 mg / m2 + adriamycin 50 mg / m2 + cyclophosphamide 500 mg / m2) for 6 cycles, 21 days was a cycle.
Docetaxel +CisplatinDrug
Also called TP regimen group
The experimental group was treated with TP (docetaxel 75mg/m2 day 1 + cisplatin 25 mg/m2 day 1,2,3) neoadjuvant chemotherapy for 6 cycles, 21 days as a cycle.
| Study group | Role | What they receive |
|---|---|---|
| TAC regimen group | Placebo comparator | The control group was treated with TAC (docetaxel 75mg/m2 + adriamycin 50mg /m2 + cyclophosphamide 500mg/m2) for 6 cycles, 21 days as a cycle. Receives: Drug: Docetaxel +doxorubicin+ cyclophosphamide |
| TP regimen group | Experimental | The experimental group was treated with TP (docetaxel 75mg/m2 day 1 + cisplatin 25 mg/m2 day 1,2,3) neoadjuvant chemotherapy for 6 cycles, 21 days as a cycle. Receives: Drug: Docetaxel +Cisplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
The pathological complete remission rate (pCR rate)
Pathological complete response rate (PCR rate), which means there is no invasive cancer (i.e. ypT0/is, ypN0) in the excised specimen (breast+lymphnode) following neoadjuvant chemotherapy and surgery.
Measured: Immediately after surgery
Secondary outcomes (4)
Event free survival rate (EFS)
Time from randomization to any of the following events: disease progression during neoadjuvant therapy, local or remote recurrence, second primary malignant tumor (breast cancer or other cancers) or death from any cause.
Measured: 5 years after surgery
Clinical response rate (CRR)
CRR judged based on RECIST v1.1
Measured: before breast cancer surgery
Breast -conserving rate
Breast -conserving rate
Measured: up to 24 weeks
Number of adverse events and serious adverse events
Evaluate the nature, incidence and severity of chemotherapy adverse events according to CTCAE 4.0
Measured: After each cycle of chemotherapy (21 days as 1 cycle)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2020
- Study start23 Nov 2018
- Primary completion26 Nov 2022
- Study completion26 Nov 2022
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.
- More trials run by Henan Cancer 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 212 participants (actual)
Sponsor and investigators
- Lead sponsor
- Henan Cancer Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Zhenzhen Liu, Henan Cancer Hospital
- Investigators
- Zhenzhen Liu, Study director, Henan Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04664972
- Sponsor's protocol ID
- HELEN-001
- Status last verified
- Sep 2024
- First submitted
- 9 Nov 2020
- Last updated
- 20 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing TP (Docetaxel + Cisplatin) and TAC (Docetaxel + Doxorubicin + Cyclophosphamide) in Neoadjuvant Therapy for Operable Triple Negative Breast Cancer, A Multicenter, Randomized, Phase II Clinical Trial
- ClinicalTrials.gov ID
- NCT04664972
- Acronym / sponsor ID
- HELEN-001
- Conditions
- Triple Negative Breast Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 212 participants (actual)
- Lead sponsor
- Henan Cancer HospitalOther government
- Study start
- 23 Nov 2018 (actual)
- Primary completion
- 26 Nov 2022 (actual)
- Study completion
- 26 Nov 2022 (actual)
- First posted
- 11 Dec 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.
Previous studies have shown that TNBC is sensitive to DNA crosslinking-related chemotherapeutic drugs such as platinum. However, there is a lack of large sample prospective clinical data to compare the efficacy of TP and EC-T / TEC regimen in the neoadjuvant chemotherapy of TNBC. Besides, the application of anthracycline drugs is limited to a certain extent due to the cardiotoxicity. Based on the above evidence, the researchers hope to explore a more effective and safer new adjuvant therapy for TNBC.
Detailed description
In this study, TNBC patients were randomly divided into experimental group and control group, the ratio of experimental group to control group was 1:1. The experimental group received 6 cycles of neoadjuvant chemotherapy (docetaxel 75 mg / m2 day 1 + cisplatin 25 mg / m2 day 1, 2, 3), 21 days as a cycle. The control group was treated with TAC (docetaxel 75mg / M2 + adriamycin 50mg / M2 + cyclophosphamide 500mg / m2) for 6 cycles, 21 days as a cycle. To compare the efficacy and safety of 6*TP (docetaxel + cisplatin) regimen and traditional 6*TAC (docetaxel + doxorubicin + cyclophosphamide) regimen in neoadjuvant chemotherapy of TNBC.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TAC regimen group | Placebo comparator | Drug: Docetaxel +doxorubicin+ cyclophosphamideThe control group was treated with TAC (docetaxel 75mg/m2 + adriamycin 50mg /m2 + cyclophosphamide 500mg/m2) for 6 cycles, 21 days as a cycle. |
| TP regimen group | Experimental | Drug: Docetaxel +CisplatinThe experimental group was treated with TP (docetaxel 75mg/m2 day 1 + cisplatin 25 mg/m2 day 1,2,3) neoadjuvant chemotherapy for 6 cycles, 21 days as a cycle. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- Age: 18-70.
- Clinical stage Ⅱ-Ⅲ.
- triple negative and invasive breast cancer confirmed by histopathology:
- With clinically measurable focus: Measurable lesions observed on ultrasound, mammography, or magnetic resonance imaging (optional) within the month prior to randomization.
- Organ and bone marrow function tests within 1 month before chemotherapy indicate no contraindications to chemotherapy:
Key exclusion criteria (5 listed)
- Evidence of metastatic breast cancer (excluding metastatic breast cancer, a chest CT, abdominal ultrasound, or CT and bone scanning should be performed at any time point before diagnosis and randomization; PET/CT scanning can be used as an alternative imaging examination mean) .
- The patients have received chemotherapy, endocrine therapy, targeted therapy, and radiation therapy for this disease.
- The patient has a second primary malignant tumor, except for:
- Due to severe and uncontrollable other medical diseases, researchers believe the existence of chemotherapy contraindications.
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 |
|---|---|---|
| Docetaxel +doxorubicin+ cyclophosphamideAlso: TAC regimen groupThe control group was treated with TAC (docetaxel 75 mg / m2 + adriamycin 50 mg / m2 + cyclophosphamide 500 mg / m2) for 6 cycles, 21 days was a cycle. | Drug | TAC regimen group |
| Docetaxel +CisplatinAlso: TP regimen groupThe experimental group was treated with TP (docetaxel 75mg/m2 day 1 + cisplatin 25 mg/m2 day 1,2,3) neoadjuvant chemotherapy for 6 cycles, 21 days as a cycle. | Drug | TP regimen group |
Primary outcome
The pathological complete remission rate (pCR rate)
Time frame: Immediately after surgery
Pathological complete response rate (PCR rate), which means there is no invasive cancer (i.e. ypT0/is, ypN0) in the excised specimen (breast+lymphnode) following neoadjuvant chemotherapy and surgery.
4 secondary outcomes
Event free survival rate (EFS)
Time frame: 5 years after surgery
Clinical response rate (CRR)
Time frame: before breast cancer surgery
Breast -conserving rate
Time frame: up to 24 weeks
Number of adverse events and serious adverse events
Time frame: After each cycle of chemotherapy (21 days as 1 cycle)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Sep 2024.
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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.
Zhenzhen Liu study director
Henan Cancer 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 Docetaxel +doxorubicin+ cyclophosphamide and Docetaxel +Cisplatin in people with Triple Negative Breast Cancer, run by Henan Cancer 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 18 inclusion and 5 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: finished, as of the sponsor's last update on 20 Sep 2024. 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
The pathological complete remission rate (pCR rate) (time frame: Immediately after surgery). 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 20 Sep 2024.