Triple Negative Breast CancerPhase 4NCT03799679
Albumin-Bound Paclitaxel Followed by Epirubicin in Combination With Cyclophosphamide in Triple Negative Breast Cancer
A Phase 4 study testing Chemotherapeutic Agent in people with Triple Negative Breast Cancer, run by Fudan University at 1 site in China.
Trial summary
This is an open-label, single arm, two-stage Simon Design study for women with Triple Negative Breast Cancer treated with Nanoparticle Albumin-Bound Paclitaxel and Carboplatin. The primary objective of the trial is to evaluate of the efficacy and safety of weekly Nanoparticle Albumin-Bound Paclitaxel(Nab-P) Followed… 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?
- Chemotherapeutic Agent
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 26 Nov 2018to 1 Feb 2020
- Phase
- Phase 4
- 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: from 18 to 70 years old, female.
- Has histologically or cytologically confirmed unilateral primary invasive breast cancer with a clinical stage of T2-4NanyM0.
- The expression of ER, PR, HER-2 was negative by immunohistochemistry (IHC), if HER2 expression is 2+ patients need to be confirmed by in situ hybridization to detect no HER-2 gene amplification.
- At least one measurable objective lesion according to RECIST 1.1 criteria.
- ECOG performance status of 0-1.
- LVEF≥55%.
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- Bone marrow function: Neutrophils ≥ 1.5×109/L, platelets ≥ 100×109/L, and hemoglobin ≥ 90 g/L.
- Liver and renal function: Serum creatinine ≤ 1.5 times the upper limit of normal. AST and ALT ≤ 2.5 times the upper limit of normal Total bilirubin ≤ 1.5 times the upper limit of normal, or ≤ 2.5 times the upper limit of normal in patients with Gilbert's syndrome.
- Has good compliance with the planned treatment, understand the study process and sign written informed consent.
Who cannot join
- Any prior cytotoxic chemotherapy, endocrine therapy, biological therapy, or radiation therapy.
- Patients with grade II or higher heart disease scored by the New York Heart Association (NYHA).
- Severe systemic infection, or with other serious diseases.
- Patients with known hypersensitivity or intolerance to chemotherapeutic agents or their excipients.
- Other malignancies have occurred in the past 5 years, except for cured cervical carcinoma in situ, non-melanoma skin carcinoma.
- Pregnant or lactating, and who refuse to take appropriate contraception during the course of this trial.
- Have participated in other study studies within 30 days prior to the first dose of study drug.
- Patients who, in the opinion of the Investigator, are not suitable for participation in the study.
Trial locations and contacts
1 site in 1 country.
Yin Liu contact
China1 site, 1 recruiting
- Recruiting
Cancer Hospital/ Institute, Fudan University
Shanghai, Shanghai Municipality, 200032
Zhimin Shao, M.D., 862164175590 ext. 8808, zhimingshao@yahoo.com
About this study
Official title: Nanoparticle Albumin-Bound Paclitaxel Followed by Dose-Intensive Epirubicin in Combination With Cyclophosphamide as Neoadjuvant Chemotherapy in Triple Negative Breast Cancer
This is an open-label, single arm, two-stage Simon Design study for women with Triple Negative Breast Cancer treated with Nanoparticle Albumin-Bound Paclitaxel and Carboplatin.
The primary objective of the trial is to evaluate of the efficacy and safety of weekly Nanoparticle Albumin-Bound Paclitaxel(Nab-P) Followed by Dose-Intensive Epirubicin in Combination with Cyclophosphamide as Neoadjuvant Chemotherapy in Triple Negative Breast Cancer.
Read more
The primary endpoint of the study is to to assess Pathological complete response rate（pCR）using the Response Evaluation Criteria in Solid Tumors (RECIST 1.1)..
The total number of patients to be included in this study is 60 patients.
The duration of the study, from first patient visit to last patient visit will be approximately 19 months.
- Conditions
- Triple Negative Breast Cancer
- Being tested
- Chemotherapeutic Agent
- Keywords
- Neoadjuvant 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.
Chemotherapeutic AgentDrug
Drug: Nanoparticle Albumin-Bound Paclitaxel Nanoparticle Albumin-Bound Paclitaxel 125mg/m2, iv, d1. Patients will receive this as a single-agent for the first twelve weeks, then followed by epirubicin in combination with cyclophosphamide.
Drug: Epirubicin 90 mg/m² given IV
Drug: Cyclophosphamide 600 mg/m² given IV
| Study group | Role | What they receive |
|---|---|---|
| Chemotherapy | Experimental | Nanoparticle Albumin-Bound Paclitaxel 125mg/m2, iv, d1* 12 cycles ( weekly), followed by epirubicin 90mg/m2, iv, d1 + cyclophosphamide 600mg/m2, iv, d1 * 4 cycles (14 days per cycle) Receives: Drug: Chemotherapeutic Agent |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary endpoint is pathological complete remission (pCR)
Histopathological examination of breast and axillary lymph node specimens without invasive cancer cell remnants. Complete pathological response is also considered to be achieved if only in situ cancer cell remnants are present in the surgical specimens.
Measured: 2 months
Secondary outcomes (3)
The second endpoint includes the objective response rate (ORR)
The second endpoint ORR composed of tumor response classifications of complete response (CR) and partial response (PR), refers to the number of cases with complete and partial response after treatment as a percentage of the total number of evaluable cases.
Measured: 2 months
Breast conserving surgery(BCS) rate
Percentage of patients undergoing breast-conserving surgery after neoadjuvant therapy as a whole evaluable.
Measured: 2 months
Adverse events (AE)
Adverse events (AE) were monitored on an ongoing basis and classified according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 4.03. Patients were assessed for toxicities before each administration, and toxicity was graded accordingly.
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2019
- Study start26 Nov 2018
- Primary completion30 Nov 2019 (estimated)
- Study completion1 Feb 2020 (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 Triple Negative Breast CancerStudies of the same condition, open and under way.
- More trials run by Fudan 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This is an open-label, single arm, two-stage Simon Design study for women with Triple Negative Breast Cancer. Patients will treated by Nanoparticle Albumin-Bound Paclitaxel Followed by Dose-Intensive Epirubicin in Combination with Cyclophosphamide.
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhimin Shao, Fudan University
- Investigators
- Zhimin Shao, Principal investigator, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03799679
- Sponsor's protocol ID
- 1808189-7
- Status last verified
- Jan 2019
- First submitted
- 8 Jan 2019
- Last updated
- 10 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Liu Y, Fan L, Wang ZH, Shao ZM. Nab-paclitaxel Followed by Dose-dense Epirubicin/Cyclophosphamide in Neoadjuvant Chemotherapy for Triple-negative Breast Cancer: A Phase II Study. Oncologist. 2023 Jan 18;28(1):86-e76. doi: 10.1093/oncolo/oyac223.
PubMed 36426808
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nanoparticle Albumin-Bound Paclitaxel Followed by Dose-Intensive Epirubicin in Combination With Cyclophosphamide as Neoadjuvant Chemotherapy in Triple Negative Breast Cancer
- ClinicalTrials.gov ID
- NCT03799679
- Acronym / sponsor ID
- 1808189-7
- Conditions
- Triple Negative Breast Cancer
- Keywords
- Neoadjuvant Chemotherapy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 26 Nov 2018 (actual)
- Primary completion
- 30 Nov 2019 (estimated)
- Study completion
- 1 Feb 2020 (estimated)
- First posted
- 10 Jan 2019 (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 is an open-label, single arm, two-stage Simon Design study for women with Triple Negative Breast Cancer treated with Nanoparticle Albumin-Bound Paclitaxel and Carboplatin.
The primary objective of the trial is to evaluate of the efficacy and safety of weekly Nanoparticle Albumin-Bound Paclitaxel(Nab-P) Followed by Dose-Intensive Epirubicin in Combination with Cyclophosphamide as Neoadjuvant Chemotherapy in Triple Negative Breast Cancer.
The primary endpoint of the study is to to assess Pathological complete response rate（pCR）using the Response Evaluation Criteria in Solid Tumors (RECIST 1.1)..
The total number of patients to be included in this study is 60 patients.
The duration of the study, from first patient visit to last patient visit will be approximately 19 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is an open-label, single arm, two-stage Simon Design study for women with Triple Negative Breast Cancer. Patients will treated by Nanoparticle Albumin-Bound Paclitaxel Followed by Dose-Intensive Epirubicin in Combination with Cyclophosphamide.
| Arm | Type | Receives |
|---|---|---|
| Chemotherapy | Experimental | Drug: Chemotherapeutic AgentNanoparticle Albumin-Bound Paclitaxel 125mg/m2, iv, d1* 12 cycles ( weekly), followed by epirubicin 90mg/m2, iv, d1 + cyclophosphamide 600mg/m2, iv, d1 * 4 cycles (14 days per cycle) |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age: from 18 to 70 years old, female.
- Has histologically or cytologically confirmed unilateral primary invasive breast cancer with a clinical stage of T2-4NanyM0.
- The expression of ER, PR, HER-2 was negative by immunohistochemistry (IHC), if HER2 expression is 2+ patients need to be confirmed by in situ hybridization to detect no HER-2 gene amplification.
- At least one measurable objective lesion according to RECIST 1.1 criteria.
- ECOG performance status of 0-1.
Key exclusion criteria (8 listed)
- Any prior cytotoxic chemotherapy, endocrine therapy, biological therapy, or radiation therapy.
- Patients with grade II or higher heart disease scored by the New York Heart Association (NYHA).
- Severe systemic infection, or with other serious diseases.
- Patients with known hypersensitivity or intolerance to chemotherapeutic agents or their excipients.
- Other malignancies have occurred in the past 5 years, except for cured cervical carcinoma in situ, non-melanoma skin carcinoma.
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 |
|---|---|---|
| Chemotherapeutic AgentDrug: Nanoparticle Albumin-Bound Paclitaxel Nanoparticle Albumin-Bound Paclitaxel 125mg/m2, iv, d1. Patients will receive this as a single-agent for the first twelve weeks, then followed by epirubicin in combination with cyclophosphamide. Drug: Epirubicin 90 mg/m² given IV Drug: Cyclophosphamide 600 mg/m² given IV | Drug | Chemotherapy |
Primary outcome
The primary endpoint is pathological complete remission (pCR)
Time frame: 2 months
Histopathological examination of breast and axillary lymph node specimens without invasive cancer cell remnants. Complete pathological response is also considered to be achieved if only in situ cancer cell remnants are present in the surgical specimens.
3 secondary outcomes
The second endpoint includes the objective response rate (ORR)
Time frame: 2 months
Breast conserving surgery(BCS) rate
Time frame: 2 months
Adverse events (AE)
Time frame: 2 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2019.
- Derived from this study: PubMed 36426808Liu Y, Fan L, Wang ZH, Shao ZM. Nab-paclitaxel Followed by Dose-dense Epirubicin/Cyclophosphamide in Neoadjuvant Chemotherapy for Triple-negative Breast Cancer: A Phase II Study. Oncologist. 2023 Jan 18;28(1):86-e76. doi: 10.1093/oncolo/oyac223.
- Individual participant dataSharing planned: Undecided
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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.
Yin Liu contact
Zhimin Shao principal investigator
Fudan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Chemotherapeutic Agent in people with Triple Negative Breast Cancer, run by Fudan University 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 9 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 10 Jan 2019. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 Zhimin Shao (18017312288, szm@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary endpoint is pathological complete remission (pCR) (time frame: 2 months). 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 NCT03799679, 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 10 Jan 2019.