Breast NeoplasmsPhase 3NCT02613026
Comparative Analysis of the Efficacies in Neoadjuvant Chemotherapy of Breast Cancer
A Phase 3 study testing Pirarubicin, Docetaxel and Cyclophosphamide in people with Breast Neoplasms, run by 307 Hospital of PLA at 5 sites in China.
Trial summary
The purpose of this study is to compare the short-term and long-term efficacies and the safeties of pirarubicin plus docetaxel(AT group) and pirarubicin plus cyclophosphamide followed by docetaxel(AC-T group) in neoadjuvant chemotherapy of breast cancer. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Breast Neoplasms
- What is being tested?
- Pirarubicin, Docetaxel and Cyclophosphamide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 104 participants
- Where
- 5 sitesChina
- Study dates
- Jul 2009to Feb 2015
- 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 18 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- histopathologically diagnosed with stage I-III breast cancers;
- clearly confirmed ER, PR and HER2 statuses;
- the state of axillary lymph nodes was determined through the relevant examination steps (puncture or sentinel lymph node biopsy);
- the patients were not treated with neoadjuvant therapy and surgery.
Who cannot join
- the patients whose breasts or axillary lumps had received excision biopsy;
- the patients who had severely abnormal organ functions or who could not tolerate chemotherapy,
- the patients with severe concomitant diseases;
- the patients with heart disease or left ventricular ejection fraction (LVEF) <50%.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
China5 sites
Hunan Provincial People's Hospital
Changsha, Hunan, 410005
Xiangya Hospital, Central South University
Changsha, Hunan, 410008
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, 150081
Jiangsu Cancer Hospital
Nanjing, Jiangsu, 210000
The fourth hospital of Hebei Medical University
Shijiazhuang, Hebei, 050010
About this study
Official title: Comparative Analysis of the Efficacies of AT and AC-T Regimens in Neoadjuvant Chemotherapy of Breast Cancer
The purpose of this study is to compare the short-term and long-term efficacies and the safeties of pirarubicin plus docetaxel(AT group) and pirarubicin plus cyclophosphamide followed by docetaxel(AC-T group) in neoadjuvant chemotherapy of breast cancer.
Read the detailed description
Based on the results of NSABP(National Surgical Adjuvant Breast and Bowel Project) B27 trial, anthracyclines(A) and Taxanes(T) are most commonly recommended in neoadjuvant chemotherapy of breast cancer.
Pirarubicin is one of anthracyclines and by embedding the DNA double stranded, which inhibits DNA replication and RNA synthesis, thereby impedes the rapid growth of cancer cells.
Docetaxel in one of taxanes and by strengthening the tubulin polymerization, inhibiting of microtubule depolymerization and leading to the formation of stable non functional microtubule bundles, which destroys mitosis of tumor cells.
- Conditions
- Breast Neoplasms
- Being tested
- Pirarubicin, Docetaxel, Cyclophosphamide
- Keywords
- Breast tumor, Neoadjuvant chemotherapy, Pathological complete remission
- Medical subject headings
- Breast Neoplasms, Pathologic Complete Response
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PirarubicinDrug
Also called Tetrahydropyranyl Adriamycin
DocetaxelDrug
Also called Taxotere
CyclophosphamideDrug
| Study group | Role | What they receive |
|---|---|---|
| Combined therapy group | Experimental | pirarubicin 50mg/m2, iv, d1; docetaxel 75mg/m2, div, d1. 21 days were a cycle of treatment, with a total of 4-8 cycles. Receives: Drug: Pirarubicin; Drug: Docetaxel |
| Sequential therapy group | Experimental | cyclophosphamide 600mg/m2, iv, d1; Pirarubicin 60mg/m2, iv, d1, 21 days were a cycle of treatment, with a total of 4 cycles. Then followed by Docetaxel 75- 100mg/m2, div, d1, 21 days were a cycle of treatment, with a total of 4 cycles. Receives: Drug: Pirarubicin; Drug: Docetaxel; Drug: Cyclophosphamide |
What is being measured
The primary outcome is the main question the study is designed to answer.
pathological complete response rate
Measured: one year
Secondary outcomes (3)
clinical response rate
Measured: one year
Percentage of changes in hormone receptors status after treatment
Measured: one year
Number of relative prognostic factors which influence pCR
Measured: three years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2015 (estimated)
- Study startJul 2009
- Primary completionMar 2013
- Study completionFeb 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Breast NeoplasmsStudies 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
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- 307 Hospital of PLA
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shikai Wu, 307 Hospital of PLA
- Investigators
- Shikai Wu, Principal investigator, 307 Hospital of PLA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02613026
- Sponsor's protocol ID
- AT2009
- Status last verified
- Nov 2015
- First submitted
- 3 Nov 2015
- Last updated
- 24 Nov 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Kaufmann M, Hortobagyi GN, Goldhirsch A, Scholl S, Makris A, Valagussa P, Blohmer JU, Eiermann W, Jackesz R, Jonat W, Lebeau A, Loibl S, Miller W, Seeber S, Semiglazov V, Smith R, Souchon R, Stearns V, Untch M, von Minckwitz G. Recommendations from an international expert panel on the use of neoadjuvant (primary) systemic treatment of operable breast cancer: an update. J Clin Oncol. 2006 Apr 20;24(12):1940-9. doi: 10.1200/JCO.2005.02.6187.
PubMed 16622270Bear HD, Anderson S, Brown A, Smith R, Mamounas EP, Fisher B, Margolese R, Theoret H, Soran A, Wickerham DL, Wolmark N; National Surgical Adjuvant Breast and Bowel Project Protocol B-27. The effect on tumor response of adding sequential preoperative docetaxel to preoperative doxorubicin and cyclophosphamide: preliminary results from National Surgical Adjuvant Breast and Bowel Project Protocol B-27. J Clin Oncol. 2003 Nov 15;21(22):4165-74. doi: 10.1200/JCO.2003.12.005. Epub 2003 Oct 14.
PubMed 14559892Mamounas EP, Brown A, Anderson S, Smith R, Julian T, Miller B, Bear HD, Caldwell CB, Walker AP, Mikkelson WM, Stauffer JS, Robidoux A, Theoret H, Soran A, Fisher B, Wickerham DL, Wolmark N. Sentinel node biopsy after neoadjuvant chemotherapy in breast cancer: results from National Surgical Adjuvant Breast and Bowel Project Protocol B-27. J Clin Oncol. 2005 Apr 20;23(12):2694-702. doi: 10.1200/JCO.2005.05.188.
PubMed 15837984
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Analysis of the Efficacies of AT and AC-T Regimens in Neoadjuvant Chemotherapy of Breast Cancer
- ClinicalTrials.gov ID
- NCT02613026
- Acronym / sponsor ID
- AT2009
- Conditions
- Breast Neoplasms
- Keywords
- Breast tumor, Neoadjuvant chemotherapy, Pathological complete remission
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- 307 Hospital of PLAUniversity, hospital or other
- Study start
- Jul 2009
- Primary completion
- Mar 2013 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 24 Nov 2015 (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.
The purpose of this study is to compare the short-term and long-term efficacies and the safeties of pirarubicin plus docetaxel(AT group) and pirarubicin plus cyclophosphamide followed by docetaxel(AC-T group) in neoadjuvant chemotherapy of breast cancer.
Detailed description
Based on the results of NSABP(National Surgical Adjuvant Breast and Bowel Project) B27 trial, anthracyclines(A) and Taxanes(T) are most commonly recommended in neoadjuvant chemotherapy of breast cancer.
Pirarubicin is one of anthracyclines and by embedding the DNA double stranded, which inhibits DNA replication and RNA synthesis, thereby impedes the rapid growth of cancer cells.
Docetaxel in one of taxanes and by strengthening the tubulin polymerization, inhibiting of microtubule depolymerization and leading to the formation of stable non functional microtubule bundles, which destroys mitosis of tumor cells.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Combined therapy group | Experimental | Drug: Pirarubicin, Drug: Docetaxelpirarubicin 50mg/m2, iv, d1; docetaxel 75mg/m2, div, d1. 21 days were a cycle of treatment, with a total of 4-8 cycles. |
| Sequential therapy group | Experimental | Drug: Pirarubicin, Drug: Docetaxel, Drug: Cyclophosphamidecyclophosphamide 600mg/m2, iv, d1; Pirarubicin 60mg/m2, iv, d1, 21 days were a cycle of treatment, with a total of 4 cycles. Then followed by Docetaxel 75- 100mg/m2, div, d1, 21 days were a cycle of treatment, with a total of 4 cycles. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- histopathologically diagnosed with stage I-III breast cancers;
- clearly confirmed ER, PR and HER2 statuses;
- the state of axillary lymph nodes was determined through the relevant examination steps (puncture or sentinel lymph node biopsy);
- the patients were not treated with neoadjuvant therapy and surgery.
Key exclusion criteria (4 listed)
- the patients whose breasts or axillary lumps had received excision biopsy;
- the patients who had severely abnormal organ functions or who could not tolerate chemotherapy,
- the patients with severe concomitant diseases;
- the patients with heart disease or left ventricular ejection fraction (LVEF) <50%.
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 |
|---|---|---|
| PirarubicinAlso: Tetrahydropyranyl Adriamycin | Drug | Combined therapy group, Sequential therapy group |
| DocetaxelAlso: Taxotere | Drug | Combined therapy group, Sequential therapy group |
| Cyclophosphamide | Drug | Sequential therapy group |
Primary outcome
pathological complete response rate
Time frame: one year
3 secondary outcomes
clinical response rate
Time frame: one year
Percentage of changes in hormone receptors status after treatment
Time frame: one year
Number of relative prognostic factors which influence pCR
Time frame: three years
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 24 Nov 2015.
- Background: PubMed 16622270Kaufmann M, Hortobagyi GN, Goldhirsch A, Scholl S, Makris A, Valagussa P, Blohmer JU, Eiermann W, Jackesz R, Jonat W, Lebeau A, Loibl S, Miller W, Seeber S, Semiglazov V, Smith R, Souchon R, Stearns V, Untch M, von Minckwitz G. Recommendations from an international expert panel on the use of neoadjuvant (primary) systemic treatment of operable breast cancer: an update. J Clin Oncol. 2006 Apr 20;24(12):1940-9. doi: 10.1200/JCO.2005.02.6187.
- Background: PubMed 14559892Bear HD, Anderson S, Brown A, Smith R, Mamounas EP, Fisher B, Margolese R, Theoret H, Soran A, Wickerham DL, Wolmark N; National Surgical Adjuvant Breast and Bowel Project Protocol B-27. The effect on tumor response of adding sequential preoperative docetaxel to preoperative doxorubicin and cyclophosphamide: preliminary results from National Surgical Adjuvant Breast and Bowel Project Protocol B-27. J Clin Oncol. 2003 Nov 15;21(22):4165-74. doi: 10.1200/JCO.2003.12.005. Epub 2003 Oct 14.
- Background: PubMed 15837984Mamounas EP, Brown A, Anderson S, Smith R, Julian T, Miller B, Bear HD, Caldwell CB, Walker AP, Mikkelson WM, Stauffer JS, Robidoux A, Theoret H, Soran A, Fisher B, Wickerham DL, Wolmark N. Sentinel node biopsy after neoadjuvant chemotherapy in breast cancer: results from National Surgical Adjuvant Breast and Bowel Project Protocol B-27. J Clin Oncol. 2005 Apr 20;23(12):2694-702. doi: 10.1200/JCO.2005.05.188.
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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.
Shikai Wu principal investigator
307 Hospital of PLA
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Pirarubicin, Docetaxel and Cyclophosphamide in people with Breast Neoplasms, run by 307 Hospital of PLA at 5 sites 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 4 inclusion and 4 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 24 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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 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?
pathological complete response rate (time frame: one year). 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 NCT02613026, which also lists 3 linked publications.
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 24 Nov 2015.