Breast CancerPhase 3TaiNACNCT00776724
Tailored Neoadjuvant Chemotherapy for Stage II/III Breast Cancer With Tumor Size More Than 2 cm
A Phase 3 study testing Taxotere , Epirubicin and E-HDFL,EP,TE,N-HDFL,NP,T-HDFL,TP in people with Breast Cancer and Chemotherapy, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
This is a multi-center randomized phase III trial. The purpose is to evaluate and compare the pathological complete response (pCR) rates after neoadjuvant chemotherapy with tailored chemotherapeutic regimens or standard chemotherapy for stage II/III breast cancer with tumor size more than 2 cm. Read more about this study
- Who is it for?
- Ages 20 years and older, women only
- Conditions the study is for
- Breast Cancer, Chemotherapy
- What is being tested?
- Taxotere , Epirubicin and E-HDFL,EP,TE,N-HDFL,NP,T-HDFL,TP
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 166 participants
- Where
- 1 siteTaiwan
- Study dates
- 29 May 2008to 19 Apr 2017
- 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 20 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically confirmed invasive, but non-inflammatory, breast carcinoma, with stage II or III disease (AJCC 7th ed)
- And, tumor size more than 2 cm in greatest diameter measured by estimated by CT scan or MRI
- Documented Her2/neu negative , including score 0, 1+, or 2+ by immunohistochemistry
- No prior radiotherapy, hormonal therapy or chemotherapy for invasive breast cancer
- Performance status of ECOG 0, 1,
- Female with age older than 20 years
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- Laboratory parameter
- Absolute neutrophil count (ANC) ≧1500/mm3
- Total bilirubin ≦2.0 times the upper limit of normal (ULM)
- AST or ALT ≦2.5 times the upper limit of normal (ULM)
- Platelets ≧100,000/mm3
- Serum creatinine ≦1.5 x ULM
- Fasting triglyceride ≧ 70 mg/dL
- Ability to understand and willingness to sign a written informed consent document.
Who cannot join
- Evidence of metastatic breast cancer or inflammatory breast cancer
- Bilateral breast cancer, metaplastic carcinoma, or mucinous carcinoma
- Known allergy to any of the study drugs or to agents containing Cremophor.
- Serious intercurrent infections or medical illnesses that are uncontrolled or the control of which may be jeopardized by this therapy
- Psychiatric disorders or other conditions regarding the subject incapable of complying with the requirements of the protocol
- Evidence of baseline sensory or motor neuropathy
- Pregnant or breast feeding women
- Previous or current systemic malignancy with the exception of curatively treated non-melanoma skin cancer or cervical carcinoma in situ with a disease-free interval of at least 5 years
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Phase III Study of Docetaxel/ Epirubicin Versus Tailored Regimens as Neoadjuvant Chemotherapy for Stage II/III Breast Cancer With Tumor Size More Than 2 cm
This is a multi-center randomized phase III trial. The purpose is to evaluate and compare the pathological complete response (pCR) rates after neoadjuvant chemotherapy with tailored chemotherapeutic regimens or standard chemotherapy for stage II/III breast cancer with tumor size more than 2 cm.
Read the detailed description
This is a multicenter randomized phase III trial. The purpose is to evaluate and compare the pathological complete response (pCR) rates after neoadjuvant chemotherapy with tailored chemotherapeutic regimens or standard chemotherapy for stage II/III breast cancer with tumor size more than 2 cm.
For primary operable breast cancer, neoadjuvant chemotherapy is one of standard options. Pathological complete response (pCR) was associated with significantly improved long-term disease free and overall survival. Anthracycline/taxane-based chemotherapy regimens have been studied extensively in prospective trials and are the most frequently prescribed treatments in patients with breast cancer as neoadjuvant chemotherapy. Regimens that have been tested in large multicenter phase III trials and yielded pCR rates of at around 15% and up to 20% after 6 cycles of chemotherapy. Recent evidences have showed that the expression of several proteins in the tumor samples such as tau, topoisomerase II alpha (topo II), and ERCC1 can predict the tumor response to taxanes, anthracyclines, and platinums, respectively. We hypothesized that select chemotherapeutic agent according the expressions of drug sensitivity predictive biomarkers from patient's tumor sample may improve the efficacy of breast cancer treatment.
In this randomized phase III trial, TE (Docetaxel/ epirubicin) will be given in control arm since it is a highly active regimen for breast cancer. In the Tailored chemotherapy arm, 7 different combination chemotherapy regimens that containing 2 drugs among taxotere, epirubicin, cisplatin, vinorelbine, and 5FU, will be given according to the expressions of tumor biomarkers. The doses and schedules of those regimens are selected according published 1st line protocols for breast cancer. The primary endpoint is the pCR rate. After 4 cycles of neoadjuvant chemotherapy, under the assumption of pCR rate of 15% in TE arm, to achieve 80% power at the 5% level (one side) of significance for the detection of a 15% increase of pCR rate in tailored regimen arm, 134 patients in either arm should be included in the study. If a 10% drop-out rate and multi-center study variation effect are considered, totally 316 patients will be required.
- Conditions
- Breast Cancer, Chemotherapy
- Being tested
- Taxotere , Epirubicin, E-HDFL,EP,TE,N-HDFL,NP,T-HDFL,TP
- Keywords
- breast ca, phase III, Tailored neoadjuvant chemotherapy, stage II/III
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Taxotere , EpirubicinDrug
Taxotere 70 mg/m2 1hr iv infusion / Epirubicin 90 mg/m2 (TE) iv infusion on day 1.
E-HDFL,EP,TE,N-HDFL,NP,T-HDFL,TPDrug
Tau+ topo II+ ERCC1+ : Epi 45mg/m2 iv / 5FU 2000mg/m2 + Lv 300mg/m2 24 hrs infusion, day 1 and 8.
Tau+ topo II+ ERCC1- : Epi 45mg/m2 iv/ Cis 35mg/m2 24 hrs iv infusion day 1 and 8.
Tau+ topo II- ERCC1+ : Vin 25mg/m2 iv / 5FU 2000mg/m2 + Lv 300mg/m2 24 hrs infusion, day 1 and 8.
Tau+ topo II- ERCC1- : Cis 35mg/m2 24 hrs infusion / Vin 25mg/m2 iv day 1 and 8.
Tau- topo II+ ERCC1+ : Docetaxel 70 mg/m2 / Epirubicin 90 mg/m2 on day 1.
Tau- topo II+ ERCC1- : Docetaxel 70 mg/m2 / Epirubicin 90 mg/m2 on day 1.
Tau- topo II- ERCC1+ : Tax 35mg/m2 1hr infusion / 5FU 2000mg/m2 + Lv 300mg/m2 24 hrs infusion, day 1 and 8.
Tau- topo II- ERCC1- : Tax 35mg/m2 1hr infusion / Cis 35mg/m2 24 hrs infusion day 1 and 8.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | docetaxel-epirubicin for 4 cycles before surgery Receives: Drug: Taxotere , Epirubicin |
| 2 | Experimental | Tailored regimens, base on immunohistochemical study of the tumor biopsy tissue, for 4 cycles before surgery. Receives: Drug: E-HDFL,EP,TE,N-HDFL,NP,T-HDFL,TP |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate and compare the pathological complete response (pCR) rates
Measured: operation after 4 cycles of neoadjuvant chemotherapy with tailored chemotherapeutic regimens or TE
Secondary outcomes (1)
To evaluate the overall clinical response rate
Measured: after 4 cycles of neoadjuvant chemotherapy with tailored chemotherapeutic regimens or TE
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2008 (estimated)
- Study start29 May 2008
- Primary completion30 Nov 2014
- Study completion19 Apr 2017
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.
- More trials run by National Taiwan University 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 166 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yen-Shen Lu, M.D., Ph.D., Principal investigator, Department of Oncology, National Taiwan University HospitalChiun-Sheng Hunag, MD,PhD, Principal investigator, Department of Surgery, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00776724
- Sponsor's protocol ID
- 200803006M
- Acronym
- TaiNAC
- Status last verified
- May 2019
- First submitted
- 19 Oct 2008
- Last updated
- 6 May 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Phase III Study of Docetaxel/ Epirubicin Versus Tailored Regimens as Neoadjuvant Chemotherapy for Stage II/III Breast Cancer With Tumor Size More Than 2 cm
- ClinicalTrials.gov ID
- NCT00776724
- Acronym / sponsor ID
- TaiNAC / 200803006M
- Conditions
- Breast Cancer, Chemotherapy
- Keywords
- breast ca, phase III, Tailored neoadjuvant chemotherapy, stage II/III
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 166 participants (actual)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 29 May 2008 (actual)
- Primary completion
- 30 Nov 2014 (actual)
- Study completion
- 19 Apr 2017 (actual)
- First posted
- 21 Oct 2008 (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 multi-center randomized phase III trial. The purpose is to evaluate and compare the pathological complete response (pCR) rates after neoadjuvant chemotherapy with tailored chemotherapeutic regimens or standard chemotherapy for stage II/III breast cancer with tumor size more than 2 cm.
Detailed description
This is a multicenter randomized phase III trial. The purpose is to evaluate and compare the pathological complete response (pCR) rates after neoadjuvant chemotherapy with tailored chemotherapeutic regimens or standard chemotherapy for stage II/III breast cancer with tumor size more than 2 cm.
For primary operable breast cancer, neoadjuvant chemotherapy is one of standard options. Pathological complete response (pCR) was associated with significantly improved long-term disease free and overall survival. Anthracycline/taxane-based chemotherapy regimens have been studied extensively in prospective trials and are the most frequently prescribed treatments in patients with breast cancer as neoadjuvant chemotherapy. Regimens that have been tested in large multicenter phase III trials and yielded pCR rates of at around 15% and up to 20% after 6 cycles of chemotherapy. Recent evidences have showed that the expression of several proteins in the tumor samples such as tau, topoisomerase II alpha (topo II), and ERCC1 can predict the tumor response to taxanes, anthracyclines, and platinums, respectively. We hypothesized that select chemotherapeutic agent according the expressions of drug sensitivity predictive biomarkers from patient's tumor sample may improve the efficacy of breast cancer treatment.
In this randomized phase III trial, TE (Docetaxel/ epirubicin) will be given in control arm since it is a highly active regimen for breast cancer. In the Tailored chemotherapy arm, 7 different combination chemotherapy regimens that containing 2 drugs among taxotere, epirubicin, cisplatin, vinorelbine, and 5FU, will be given according to the expressions of tumor biomarkers. The doses and schedules of those regimens are selected according published 1st line protocols for breast cancer. The primary endpoint is the pCR rate. After 4 cycles of neoadjuvant chemotherapy, under the assumption of pCR rate of 15% in TE arm, to achieve 80% power at the 5% level (one side) of significance for the detection of a 15% increase of pCR rate in tailored regimen arm, 134 patients in either arm should be included in the study. If a 10% drop-out rate and multi-center study variation effect are considered, totally 316 patients will be required.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: Taxotere , Epirubicindocetaxel-epirubicin for 4 cycles before surgery |
| 2 | Experimental | Drug: E-HDFL,EP,TE,N-HDFL,NP,T-HDFL,TPTailored regimens, base on immunohistochemical study of the tumor biopsy tissue, for 4 cycles before surgery. |
Who may qualify
- Ages
- 20 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Histologically confirmed invasive, but non-inflammatory, breast carcinoma, with stage II or III disease (AJCC 7th ed)
- And, tumor size more than 2 cm in greatest diameter measured by estimated by CT scan or MRI
- Documented Her2/neu negative , including score 0, 1+, or 2+ by immunohistochemistry
- No prior radiotherapy, hormonal therapy or chemotherapy for invasive breast cancer
- Performance status of ECOG 0, 1,
Key exclusion criteria (8 listed)
- Evidence of metastatic breast cancer or inflammatory breast cancer
- Bilateral breast cancer, metaplastic carcinoma, or mucinous carcinoma
- Known allergy to any of the study drugs or to agents containing Cremophor.
- Serious intercurrent infections or medical illnesses that are uncontrolled or the control of which may be jeopardized by this therapy
- Psychiatric disorders or other conditions regarding the subject incapable of complying with the requirements of the protocol
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 |
|---|---|---|
| Taxotere , EpirubicinTaxotere 70 mg/m2 1hr iv infusion / Epirubicin 90 mg/m2 (TE) iv infusion on day 1. | Drug | 1 |
| E-HDFL,EP,TE,N-HDFL,NP,T-HDFL,TPTau+ topo II+ ERCC1+ : Epi 45mg/m2 iv / 5FU 2000mg/m2 + Lv 300mg/m2 24 hrs infusion, day 1 and 8. Tau+ topo II+ ERCC1- : Epi 45mg/m2 iv/ Cis 35mg/m2 24 hrs iv infusion day 1 and 8. Tau+ topo II- ERCC1+ : Vin 25mg/m2 iv / 5FU 2000mg/m2 + Lv 300mg/m2 24 hrs infusion, day 1 and 8. Tau+ topo II- ERCC1- : Cis 35mg/m2 24 hrs infusion / Vin 25mg/m2 iv day 1 and 8. Tau- topo II+ ERCC1+ : Docetaxel 70 mg/m2 / Epirubicin 90 mg/m2 on day 1. Tau- topo II+ ERCC1- : Docetaxel 70 mg/m2 / Epirubicin 90 mg/m2 on day 1. Tau- topo II- ERCC1+ : Tax 35mg/m2 1hr infusion / 5FU 2000mg/m2 + Lv 300mg/m2 24 hrs infusion, day 1 and 8. Tau- topo II- ERCC1- : Tax 35mg/m2 1hr infusion / Cis 35mg/m2 24 hrs infusion day 1 and 8. | Drug | 2 |
Primary outcome
To evaluate and compare the pathological complete response (pCR) rates
Time frame: operation after 4 cycles of neoadjuvant chemotherapy with tailored chemotherapeutic regimens or TE
1 secondary outcome
To evaluate the overall clinical response rate
Time frame: after 4 cycles of neoadjuvant chemotherapy with tailored chemotherapeutic regimens or TE
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 6 May 2019.
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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.
Yen-Shen Lu, M.D., Ph.D. principal investigator
Department of Oncology, National Taiwan University Hospital
Chiun-Sheng Hunag, MD,PhD principal investigator
Department of Surgery, National Taiwan University 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 Taxotere , Epirubicin and E-HDFL,EP,TE,N-HDFL,NP,T-HDFL,TP in people with Breast Cancer and Chemotherapy, run by National Taiwan University Hospital at 1 site in Taiwan.
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 14 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: finished, as of the sponsor's last update on 6 May 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 Taiwan. 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 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?
To evaluate and compare the pathological complete response (pCR) rates (time frame: operation after 4 cycles of neoadjuvant chemotherapy with tailored chemotherapeutic regimens or TE). 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 6 May 2019.