Breast CancerPhase 2NCT02842099
Standard Chemotherapy Followed by Capecitabine as Prolonged Postoperative Adjuvant Treatment for Breast Cancer
A Phase 2 study testing TA or TAC and X in people with Breast Cancer, run by Peking Union Medical College Hospital at 1 site in China.
Trial summary
The study is a prospective, randomized phase II clinical trial, to compare the efficacy and safety profiles of standard chemotherapy versus standard chemotherapy followed by capecitabine as prolonged postoperative adjuvant treatment for breast cancer patients. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- TA or TAC and X
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 1 siteChina
- Study dates
- Jan 2014to Jan 2020
- Phase
- Phase 2
- 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 >= 18 and <= 70 years old.
- Performance status (Karnofsky index) >= 80.
- Histological diagnosis of invasive breast cancer (T1-T4,N2-3,M0). Time window between surgery and study randomization must be less than 60 days.
- Surgery must consist of mastectomy or conserving surgery with axillary lymph node dissection.
- Positive axillary lymph nodes defined as at least 1 out of 10 nodes with presence of disease. If sentinel node technique is used, sentinel node can be the only node affected.
- Status of hormone receptors, HER2 status, Ki-67 index and p53 in primary tumour. Results must be available before the adjuvant chemotherapy. All patients require the TA or TAC chemotherapy. And patients should receive the endocrine chemotherapy or anti-targeted therapy according to the hormone receptor status or HER2 status respectively.
Show all 15Show fewer
- Written informed consent. Patients are able to comply with treatment and study follow-up.
- Patients must not present evidence of metastatic disease.
- Normal electrocardiogram (EKG) in the 12 weeks prior to randomization. If needed, normal cardiac function must be confirmed by left ventricular ejection fraction (LVEF).
- Laboratory results (within 14 days prior to randomization):
- Hematology: neutrophils >= 2.0x10^9/l; platelets >= 100x10^9/l; hemoglobin >= 10 mg/dl;
- Hepatic function: total bilirubin <= 1 upper normal limit (UNL); SGOT and SGPT <= 2.5 UNL; alkaline phosphatase <= 2.5 UNL. If values of SGOT and SGPT > 1.5 UNL are associated to alkaline phosphatase > 2.5 UNL, patient is not eligible;
- Renal function: creatinine <= 175 mmol/l (2 mg/dl); creatinine clearance >= 60 ml/min.
- Complete stage workup during the 12 weeks prior to randomization (mammograms are allowed within a 20 week window). All patients must have a bilateral mammogram, thorax x-ray, abdominal echography and/or computed tomography (CT)-scan. If bone pain, and/or alkaline phosphatase elevation, a bone scintigraphy is mandatory. This test is recommended for all patients. Other tests: as clinically indicated.
- Negative pregnancy test done in the 14 prior days to randomization.
Who cannot join
- Prior systemic therapy for breast cancer.Or prior therapy with anthracyclines or taxanes (paclitaxel or docetaxel) for any malignancy.
- Prior radiotherapy for breast cancer.
- Bilateral invasive breast cancer.
- Pregnant or lactating women. Adequate contraceptive methods must be used during chemotherapy and hormone therapy treatments.
- Any N0-1 or M1 tumour.
- Pre-existing grade >= 2 motor or sensorial neurotoxicity (National Cancer Institute Common Toxicity Criteria version 2.0 [NCI CTC v-2.0]).
Show all 17Show fewer
- Any other serious medical pathology, such as congestive heart failure; unstable angina; history of myocardial infarction during the previous year; uncontrolled HA or high risk arrhythmias.
- History of neurological or psychiatric disorders, which could preclude the patients from free informed consent.
- Active uncontrolled infection.
- Active peptic ulcer; unstable diabetes mellitus.
- Previous or current history of neoplasms different from breast cancer, except for skin carcinoma, cervical in situ carcinoma, or any other tumour curatively treated and without recurrence in the last 10 years; ductal in situ carcinoma in the same breast; lobular in situ carcinoma.
- Chronic treatment with corticosteroids.
- Contraindications for corticosteroid administration.
- Concomitant treatment with raloxifene, tamoxifen or other selective estrogen receptor modulators (SERMs), either for osteoporosis treatment or for prevention. These treatments must stop before randomisation.
- Concomitant treatment with other investigational products; participation in other clinical trials with a non-marketed drug in the 20 previous days before randomization.
- Concomitant treatment with another therapy for cancer.
- Males.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Dept. Breast Surgery, PUMCH
Beijing, Beijing Municipality, 100730
Yan Lin, Doctor, +86-10-69152700, birds90@163.com
About this study
Official title: A Randomized, Phase II Study Comparing Standard Chemotherapy (TA-Taxol+Epirubicin or TAC-Taxol+Epirubicin+Cyclophosphamide) With Standard Chemotherapy (TA or TAC) Followed by Capecitabine (X) as Prolonged Postoperative Adjuvant Treatment for Breast Cancer
The study is a prospective, randomized phase II clinical trial, to compare the efficacy and safety profiles of standard chemotherapy versus standard chemotherapy followed by capecitabine as prolonged postoperative adjuvant treatment for breast cancer patients.
- Conditions
- Breast Cancer
- Being tested
- TA or TAC, X
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TA or TACDrug
Taxol, Epirubincin, with or without Cyclophosphamide
XDrug
Capecitabine
| Study group | Role | What they receive |
|---|---|---|
| TA or TAC plus X | Experimental | Standard chemotherapy (TA or TAC) followed by capecitabine 2.5g, po, qd for one year. Receives: Drug: TA or TAC; Drug: X |
| TA or TAC | Active comparator | Standard chemotherapy (TA or TAC) followed by no more chemotherapy Receives: Drug: TA or TAC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease-free survival
Measured: 5 years
Adverse event rate (CTCAE v. 3.0)
Measured: 5 years
Secondary outcomes (1)
Overall survival
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2016 (estimated)
- Study startJan 2014
- Primary completionJan 2020 (estimated)
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 Peking Union Medical College 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Qiang SUN, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02842099
- Sponsor's protocol ID
- PUMCH-BREAST-X prolong therapy
- Status last verified
- Jul 2016
- First submitted
- 17 Jul 2016
- Last updated
- 22 Jul 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Phase II Study Comparing Standard Chemotherapy (TA-Taxol+Epirubicin or TAC-Taxol+Epirubicin+Cyclophosphamide) With Standard Chemotherapy (TA or TAC) Followed by Capecitabine (X) as Prolonged Postoperative Adjuvant Treatment for Breast Cancer
- ClinicalTrials.gov ID
- NCT02842099
- Acronym / sponsor ID
- PUMCH-BREAST-X prolong therapy
- Conditions
- Breast Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Jan 2020 (estimated)
- First posted
- 22 Jul 2016 (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 study is a prospective, randomized phase II clinical trial, to compare the efficacy and safety profiles of standard chemotherapy versus standard chemotherapy followed by capecitabine as prolonged postoperative adjuvant treatment for breast cancer patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TA or TAC plus X | Experimental | Drug: TA or TAC, Drug: XStandard chemotherapy (TA or TAC) followed by capecitabine 2.5g, po, qd for one year. |
| TA or TAC | Active comparator | Drug: TA or TACStandard chemotherapy (TA or TAC) followed by no more chemotherapy |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Age >= 18 and <= 70 years old.
- Performance status (Karnofsky index) >= 80.
- Histological diagnosis of invasive breast cancer (T1-T4,N2-3,M0). Time window between surgery and study randomization must be less than 60 days.
- Surgery must consist of mastectomy or conserving surgery with axillary lymph node dissection.
- Positive axillary lymph nodes defined as at least 1 out of 10 nodes with presence of disease. If sentinel node technique is used, sentinel node can be the only node affected.
Key exclusion criteria (17 listed)
- Prior systemic therapy for breast cancer.Or prior therapy with anthracyclines or taxanes (paclitaxel or docetaxel) for any malignancy.
- Prior radiotherapy for breast cancer.
- Bilateral invasive breast cancer.
- Pregnant or lactating women. Adequate contraceptive methods must be used during chemotherapy and hormone therapy treatments.
- Any N0-1 or M1 tumour.
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 |
|---|---|---|
| TA or TACTaxol, Epirubincin, with or without Cyclophosphamide | Drug | TA or TAC, TA or TAC plus X |
| XCapecitabine | Drug | TA or TAC plus X |
Primary outcome
Disease-free survival
Time frame: 5 years
Adverse event rate (CTCAE v. 3.0)
Time frame: 5 years
1 secondary outcome
Overall survival
Time frame: 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2016.
Related trials for Breast Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 2
Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort
Invasive Mammary Carcinoma, Metastatic Breast Cancer
Not yet recruitingObservational study
Comparison of Reliability, Time Cost, and Participant Comfort of Lymphedema Assessments in Upper Extremity
Lymphedema, Upper Extremity Lymphedema
RecruitingPhase 3
A Study of Camrelizumab Plus Chemotherapy in Combination With or Without Famitinib as Neoadjuvant Therapy in Participants With Triple Negative Breast Cancer (BCTOP-T-N01)
TNBC - Triple-Negative Breast Cancer
RecruitingPhase 3
Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low Trial
Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing TA or TAC and X in people with Breast Cancer, run by Peking Union Medical College Hospital 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 15 inclusion and 17 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 22 Jul 2016. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 Yan Lin, Doctor (86-010-69152701, birds90@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disease-free survival (time frame: 5 years). The study lists 2 primary outcomes in all. 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 22 Jul 2016.