Primary Breast CancerPhase 3NCT01019616
Alternative Non-cross-resistant Adjuvant Chemotherapy for Operable Breast Cancer Non-response to Primary Chemotherapy
A Phase 3 study testing paclitaxel/anthracycline in people with Primary Breast Cancer, run by Tao OUYANG at 7 sites in China.
Trial summary
The purpose of this phase Ⅲ, multi-center, prospective, open-label, randomized,controlled study is to determine whether alternative non-cross-resistant adjuvant chemotherapy can increase distant disease free survival(DDFS) in operable patients non-response to primary chemotherapy. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Primary Breast Cancer
- What is being tested?
- paclitaxel/anthracycline
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 7 sitesChina
- Study dates
- 4 Mar 2011to 30 Jun 2022
- 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 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female patients, age ≦65 years
- Biopsy proven lymph node positive, estrogen receptor- positive primary breast cancer
- Must have completed a 4-cycle neo-adjuvant chemotherapy with a standard regimen(containing anthracycline or paclitaxel)
- Must have undergone surgery to remove the primary tumor by either a mastectomy or enlarged local excision
- Postoperative residual positive lymph nodes or G1/G2/G3 of Miller \& Payne Grading System
- Adequate recovery from recent surgery
Show all 21Show fewer
- No history of other malignancies
- No currently uncontrolled diseased or active infection
- Not pregnant or breast feeding, and on appropriate birth control if of child-bearing potential
- Adequate cardiovascular function reserve with a myocardial infarction within the past six month
- Adequate hematologic function with:
- Absolute neutrophil count (ANC) ≥1500/mm3
- Platelets ≥100,000/ mm3
- Hemoglobin ≥10 g/dL
- Adequate hepatic and renal function with:
- Serum bilirubin ≤1.5×UNL
- Alkaline phosphatase and alanine aminotransferase (ALT) ≤2.5 x ULN. (≤5 x ULN is acceptable in the setting of hepatic metastasis)
- BUN between 1.7 and 8.3 mmol/L
- Cr between 40 and 110 umol/L
- Knowledge of the investigational nature of the study and Ability to give informed consent
- Ability and willingness to comply with study procedures.
Who cannot join
- Known or suspected distant metastases
- Concurrent malignancy or history of other malignancy
- Uncontrolled diseases(e.g., heart failure, myocardial infarction within 6 months, arrhythmia, unstable diabetes, hypercalcemia) or active infection
- Geographical, social, or psychological problems that would compromise study compliance
- Known or suspected hypersensitivity to anthracycline or paclitaxel
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
China7 sites
307 Hospital of Pla
Beijing
Beijing Cancer Hospital Breast Center
Beijing
Beijing Chao-Yang Hospital
Beijing
Cancer Institution and Hospital.Chinese Academy of Medical Sciences
Beijing
Peking Union Medical College Hospital
Beijing
Peking University First Hospital
Beijing
Peking University People'S Hospital
Beijing
About this study
Official title: A Phase Ⅲ Study of Alternative Non-cross-resistant Adjuvant Chemotherapy for Operable Breast Cancer Non-response to Primary Chemotherapy
The purpose of this phase Ⅲ, multi-center, prospective, open-label, randomized,controlled study is to determine whether alternative non-cross-resistant adjuvant chemotherapy can increase distant disease free survival(DDFS) in operable patients non-response to primary chemotherapy.
- Conditions
- Primary Breast Cancer
- Being tested
- paclitaxel/anthracycline
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
paclitaxel/anthracyclineDrug
Also called Alternative Non-cross-resistant Adjuvant Chemotherapy
standard chemotherapy regimen(containing paclitaxel or anthracycline) different from primary chemotherapy(containing anthracycline or paclitaxel)
| Study group | Role | What they receive |
|---|---|---|
| Chemotherapy | Experimental | Not described Receives: Drug: paclitaxel/anthracycline |
| Control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
distant disease-free survival (DDFS)
Measured: 3 years after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2009 (estimated)
- Study start4 Mar 2011
- Primary completion30 Jun 2022 (estimated)
- Study completion30 Jun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary 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
- 400 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tao OUYANG
- Sponsor type
- University, hospital or other
- Collaborators
- Beijing Municipal Science & Technology Commission, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences, Peking University First Hospital, Peking University People's Hospital, Beijing Chao Yang Hospital, 307 Hospital of PLA
- Responsible party
- Sponsor-investigator, Tao OUYANG, Peking University
- Investigators
- Tao Ouyang, Doctor, Study chair, Beijing Cancer Hospital Breast Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01019616
- Sponsor's protocol ID
- D09050703570904
- Status last verified
- Nov 2021
- First submitted
- 24 Nov 2009
- Last updated
- 29 Nov 2021
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase Ⅲ Study of Alternative Non-cross-resistant Adjuvant Chemotherapy for Operable Breast Cancer Non-response to Primary Chemotherapy
- ClinicalTrials.gov ID
- NCT01019616
- Acronym / sponsor ID
- D09050703570904
- Conditions
- Primary Breast Cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (actual)
- Lead sponsor
- Tao OUYANGUniversity, hospital or other
- Collaborators
- Beijing Municipal Science & Technology Commission, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences, Peking University First Hospital, Peking University People's Hospital, Beijing Chao Yang Hospital, 307 Hospital of PLA
- Study start
- 4 Mar 2011 (actual)
- Primary completion
- 30 Jun 2022 (estimated)
- Study completion
- 30 Jun 2022 (estimated)
- First posted
- 25 Nov 2009 (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 phase Ⅲ, multi-center, prospective, open-label, randomized,controlled study is to determine whether alternative non-cross-resistant adjuvant chemotherapy can increase distant disease free survival(DDFS) in operable patients non-response to primary chemotherapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Chemotherapy | Experimental | Drug: paclitaxel/anthracycline |
| Control | No intervention | – |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (21 listed)
- Female patients, age ≦65 years
- Biopsy proven lymph node positive, estrogen receptor- positive primary breast cancer
- Must have completed a 4-cycle neo-adjuvant chemotherapy with a standard regimen(containing anthracycline or paclitaxel)
- Must have undergone surgery to remove the primary tumor by either a mastectomy or enlarged local excision
- Postoperative residual positive lymph nodes or G1/G2/G3 of Miller \& Payne Grading System
Key exclusion criteria (5 listed)
- Known or suspected distant metastases
- Concurrent malignancy or history of other malignancy
- Uncontrolled diseases(e.g., heart failure, myocardial infarction within 6 months, arrhythmia, unstable diabetes, hypercalcemia) or active infection
- Geographical, social, or psychological problems that would compromise study compliance
- Known or suspected hypersensitivity to anthracycline or paclitaxel
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 |
|---|---|---|
| paclitaxel/anthracyclineAlso: Alternative Non-cross-resistant Adjuvant Chemotherapystandard chemotherapy regimen(containing paclitaxel or anthracycline) different from primary chemotherapy(containing anthracycline or paclitaxel) | Drug | Chemotherapy |
Primary outcome
distant disease-free survival (DDFS)
Time frame: 3 years after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2021.
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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.
Tao Ouyang, Doctor study chair
Beijing Cancer Hospital Breast Center
7 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 paclitaxel/anthracycline in people with Primary Breast Cancer, run by Tao OUYANG at 7 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 21 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: status not confirmed, as of the sponsor's last update on 29 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 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?
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?
distant disease-free survival (DDFS) (time frame: 3 years 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 29 Nov 2021.