Sequential Neo-adjuvant Chemotherapy Followed by Capecitabine Vs. Conventional Adjuvant Chemotherapy in Breast Cancer

  • STATUS
    Recruiting
  • End date
    Feb 21, 2025
  • participants needed
    1588
  • sponsor
    First Hospital of Jilin University
Updated on 21 January 2021
renal function
cancer
carcinoma
breast cancer
capecitabine

Summary

This study evaluates whether sequential neo-adjuvant chemotherapy plus surgery followed by Capecitabine could achieve additional benefits over traditional postoperative chemotherapy. In the study group, patients that do not achieve pathological complete response(pCR) will receive sequential neo-adjuvant chemotherapy followed by Capecitabine. In the control group, patients will be treated with postoperative adjuvant chemotherapy.

Description

Neo-adjuvant chemotherapy(NAC) is a standard treatment for locally advanced breast cancer(LABC). By down-staging LABC, NAC is able to make inoperable cases operable as well as to make breast conserving surgery an option again for some patients.Neo-adjuvant chemotherapy is more and more widely used in operable breast cancer since it provides critical information on chemotherapy response. However, only 15% to 20% of the patients can benefit from Neo-adjuvant chemotherapy and achieve pCR. Although we obtained the information chemotherapy response for the rest of the patients who received Neo-adjuvant chemotherapy, there are still controversies on how the information will be used for further treatment. Therefore, it is a problem that needs resolving how these patients can benefit from the information Neo-adjuvant chemotherapy provides and whether Neo-adjuvant chemotherapy can replace conventional adjuvant chemotherapy at all. Our study aims to make Neo-adjuvant chemotherapy benefit more patients.

Registered patients in stage - A breast cancer is randomly split into two groups(study group and control group).In the study group, patients achieving pCR will be followed up for 5 years while patients that do not achieve pCR after neo-adjuvant chemotherapy will be treated with Capecitabine for 8 cycles after surgery. On the other hand, patients in the control group will accept surgeries and conventional adjuvant chemotherapies. Follow-up study will last 5 years. DFS and OS will be compared between the two groups.

This study provides an important basis and methods for the further treatment of patients after neo-adjuvant chemotherapy. It discusses whether neo-adjuvant chemotherapy could replace conventional adjuvant chemotherapy and become a new standard for breast cancer treatment.

Details
Condition Breast Neoplasm Female
Treatment Capecitabine, Neo-adjuvant Chemotherapy
Clinical Study IdentifierNCT03011060
SponsorFirst Hospital of Jilin University
Last Modified on21 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age between 18 yrs and 70 yrs?
Are you female?
Do you have Breast Neoplasm Female?
Do you have any of these conditions: Do you have Breast Neoplasm Female??
Pathologically confirmed unilateral invasive carcinoma (all pathological types)
No gross or microscopic residual tumor after resection
Clinical stage -stage A, no absolute surgical contraindications
Eastern Cooperative Oncology Group(ECOG) score 1
Accepting adjuvant chemotherapy within 15 days after surgery
No peripheral neuropathy
Normal bone marrow and organ functions
Bone marrow function: ANC1500/mm3PLT100000/mm3HGB8g/dl
Renal function: serum creatinine1.5 times the upper limit of normal(ULN), Liver function: total bilirubin 1.5 times the upper limit of normalAST2.5 times the upper limit of normalalanine aminotransferase(ALT)2.5 times the upper limit of normal
Cardiac function:LVEF50%
Signed informed consent form

Exclusion Criteria

Patients with the history of oral fluorouracil chemotherapy or Chinese medicine treatment
Patients with organ dysfunction
Renal function: serum creatinine>1.5 times the upper limit of normal
Liver function: total bilirubin>1.5 times the upper limit of normalAST>1.5 times the upper limit of normal, alanine aminotransferase(ALT)>1.5 times the upper limit of normal or alkaline phosphatase (ALP) >2.5 times the upper limit of normal
Cardiac functionLVEF<50%
Human epidermal growth factor receptor-2(HER-2) positive patients who cannot receive Herceptin treatment with a left ventricular ejection fraction(LVEF) less than 55%
Patients allergic to docetaxel, capecitabine, epirubicin and cyclophosphamide
Patients with severe systemic disease and/or uncontrollable infections
Patients with previous malignancies, including contralateral breast cancer
Patients with severe cardiovascular and cerebrovascular disease(i.e. Unstable angina, chronic cardiac failure, uncontrollable high blood pressure of >150/90 mmhg, myocardial infarction and cerebrovascular accident) history within 6 months before randomization
Pregnant or lactating women
Patients who have cognitive or psychological impairment as well as cannot understand the test program or stand side effects, which will result in a suspension of the trial program and follow-up
Patients without personal freedom or independent civil capacity
Clear my responses

How to participate?

Step 1 Connect with a site
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar
Name

Primary Contact

site
Name

Phone Email

0/250
Please verify that you are not a bot.

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Browse trials for

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note