Breast CancerPhase 3NCT05207514
Compare the Efficacy and the Safety of Taxotere and Nanoxel M as Neoadjuvant Chemotherapy in Breast Cancer
A Phase 3 study testing Nanoxel M, Taxotere and Doxorubicin in people with Breast Cancer, run by Samyang Biopharmaceuticals Corporation at 1 site in South Korea.
Trial summary
Phase III Clinical Trial to Compare the Efficacy and the Safety of AC(Doxorubicin, Cyclophosphamide) Followed by 4 Cycles Taxotere Versus AC(Doxorubicin, Cyclophosphamide) Followed by 4 Cycles Nanoxel M as Neoadjuvant Chemotherapy in Patients With Breast Cancer 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?
- Nanoxel M, Taxotere and Doxorubicin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteSouth Korea
- Study dates
- 31 Mar 2022to 9 May 2024
- 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
- Patients who were diagnosed with primary breast cancer by core biopsy
- Patients who have been identified as HER2 negative in the tissue obtained through core needle biopsy and have confirmed the positive / negative status of ER (Estrogen receptor) and Progesterone receptor (PR)
- HER2 positive is defined as IHC 3+ or FISH +
- Patinets whose TNM stage confirmed by CT or MRI (T2-T3, anyN, M0 or T1-3, N1-3, M0)
Who cannot join
- Patients who have distant metastasis
- Patients who have cystitis or urinary obstruction
- Patients who have history of thromboembolism or coagulation disorder
- Patients who have Interstitial lung disease ans liver cirrhosis ( > Child-Pugh class B)
- Patients who have Insulin-Dependent Type II diabete mellitus
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Open-label, Randomized, Active-controlled, Multicenter, Phase III Clinical Trial to Compare the Efficacy and the Safety of Taxotere and Nanoxel M as Neoadjuvant Chemotherapy in Breast Cancer
Phase III Clinical Trial to Compare the Efficacy and the Safety of AC(Doxorubicin, Cyclophosphamide) Followed by 4 Cycles Taxotere Versus AC(Doxorubicin, Cyclophosphamide) Followed by 4 Cycles Nanoxel M as Neoadjuvant Chemotherapy in Patients With Breast Cancer
Read the detailed description
The purpose of this study is to evaluate efficacy and safety of AC followed by Taxotere versus AC followed by Nanoxel M as neoadjuvant chemotherapy in breast caner patients.
- Conditions
- Breast Cancer
- Being tested
- Nanoxel M, Taxotere, Doxorubicin, Cyclophosphamide
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nanoxel MDrug
Also called polysorbate 80, ethanol free docetaxel
75 mg/m2, intravenously every 3 weeks for 4 cycles (after treatment cycles of doxorubicin and cyclophosphamide
TaxotereDrug
Also called docetaxel
75 mg/m2, intravenously every 3 weeks for 4 cycles (after treatment cycles of doxorubicin and cyclophosphamide
DoxorubicinDrug
60 mg/m2, intravenously every 3 weeks for 4 cycles. Given as first treatment with cyclophosphamide
CyclophosphamideDrug
600 mg/m2, intravenously every 3 weeks for 4 cycles. Given as first treatment with doxorubicin.
| Study group | Role | What they receive |
|---|---|---|
| Nanoxel M | Experimental | AC(Doxorubicin, Cyclophosphamide) followed by Nanoxel M Receives: Drug: Nanoxel M; Drug: Doxorubicin; Drug: Cyclophosphamide |
| Taxotere | Active comparator | AC(Doxorubicin, Cyclophosphamide) followed by Taxotere Receives: Drug: Taxotere; Drug: Doxorubicin; Drug: Cyclophosphamide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pathological complete response (pCR) rate using the definition of ypT0/Tis ypN0
H \& E staining of tissues obtained from breast and axillary lymph nodes was defined as the absence of invasive cancer, and the proportion of subjects was determined.
Measured: at the time of definitive surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2022
- Study start31 Mar 2022
- Primary completion7 Feb 2024
- Study completion9 May 2024
Why it stopped: The Decision to Terminate Early Due to Difficulties in Recruiting Participants and Conducting the Study.
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
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samyang Biopharmaceuticals Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Joohyuk Sohn, M.D.,Ph.D., Principal investigator, Severance Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05207514
- Sponsor's protocol ID
- DPMBC301
- Status last verified
- May 2023
- First submitted
- 7 Jan 2022
- Last updated
- 17 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open-label, Randomized, Active-controlled, Multicenter, Phase III Clinical Trial to Compare the Efficacy and the Safety of Taxotere and Nanoxel M as Neoadjuvant Chemotherapy in Breast Cancer
- ClinicalTrials.gov ID
- NCT05207514
- Acronym / sponsor ID
- DPMBC301
- Conditions
- Breast Cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The Decision to Terminate Early Due to Difficulties in Recruiting Participants and Conducting the Study.
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Samyang Biopharmaceuticals CorporationIndustry (pharma, biotech, devices)
- Study start
- 31 Mar 2022 (actual)
- Primary completion
- 7 Feb 2024 (actual)
- Study completion
- 9 May 2024 (actual)
- First posted
- 26 Jan 2022 (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.
Phase III Clinical Trial to Compare the Efficacy and the Safety of AC(Doxorubicin, Cyclophosphamide) Followed by 4 Cycles Taxotere Versus AC(Doxorubicin, Cyclophosphamide) Followed by 4 Cycles Nanoxel M as Neoadjuvant Chemotherapy in Patients With Breast Cancer
Detailed description
The purpose of this study is to evaluate efficacy and safety of AC followed by Taxotere versus AC followed by Nanoxel M as neoadjuvant chemotherapy in breast caner patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nanoxel M | Experimental | Drug: Nanoxel M, Drug: Doxorubicin, Drug: CyclophosphamideAC(Doxorubicin, Cyclophosphamide) followed by Nanoxel M |
| Taxotere | Active comparator | Drug: Taxotere, Drug: Doxorubicin, Drug: CyclophosphamideAC(Doxorubicin, Cyclophosphamide) followed by Taxotere |
Who may qualify
- Ages
- 19 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients who were diagnosed with primary breast cancer by core biopsy
- Patients who have been identified as HER2 negative in the tissue obtained through core needle biopsy and have confirmed the positive / negative status of ER (Estrogen receptor) and Progesterone receptor (PR)
- Patinets whose TNM stage confirmed by CT or MRI (T2-T3, anyN, M0 or T1-3, N1-3, M0)
Key exclusion criteria (5 listed)
- Patients who have distant metastasis
- Patients who have cystitis or urinary obstruction
- Patients who have history of thromboembolism or coagulation disorder
- Patients who have Interstitial lung disease ans liver cirrhosis ( > Child-Pugh class B)
- Patients who have Insulin-Dependent Type II diabete mellitus
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 |
|---|---|---|
| Nanoxel MAlso: polysorbate 80, ethanol free docetaxel75 mg/m2, intravenously every 3 weeks for 4 cycles (after treatment cycles of doxorubicin and cyclophosphamide | Drug | Nanoxel M |
| TaxotereAlso: docetaxel75 mg/m2, intravenously every 3 weeks for 4 cycles (after treatment cycles of doxorubicin and cyclophosphamide | Drug | Taxotere |
| Doxorubicin60 mg/m2, intravenously every 3 weeks for 4 cycles. Given as first treatment with cyclophosphamide | Drug | Nanoxel M, Taxotere |
| Cyclophosphamide600 mg/m2, intravenously every 3 weeks for 4 cycles. Given as first treatment with doxorubicin. | Drug | Nanoxel M, Taxotere |
Primary outcome
Pathological complete response (pCR) rate using the definition of ypT0/Tis ypN0
Time frame: at the time of definitive surgery
H \& E staining of tissues obtained from breast and axillary lymph nodes was defined as the absence of invasive cancer, and the proportion of subjects was determined.
Results and safety
The study was stopped early (reason given: The Decision to Terminate Early Due to Difficulties in Recruiting Participants and Conducting the Study.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 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.
Joohyuk Sohn, M.D.,Ph.D. principal investigator
Severance Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Nanoxel M, Taxotere and Doxorubicin in people with Breast Cancer, run by Samyang Biopharmaceuticals Corporation at 1 site 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 4 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: stopped early, as of the sponsor's last update on 17 May 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 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?
The study was stopped early (reason given: The Decision to Terminate Early Due to Difficulties in Recruiting Participants and Conducting the 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?
Pathological complete response (pCR) rate using the definition of ypT0/Tis ypN0 (time frame: at the time of definitive 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 17 May 2024.