Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:24 AM
Ignite Modification Date:
2025-12-25 @ 3:24 AM
NCT ID:
NCT01503905
Eligibility Criteria:
Inclusion Criteria:
1. The patients signed the written informed consent.
2. The patients present with operable breast cancers that were diagnosed by histopathology and have no distant metastasis.
3. The patients have no history of anti-cancer therapies including chemotherapy, radiation therapy, hormone therapy and surgical therapy.
4. The patients have normal cardiac functions by echocardiography.
5. The patients' ECOG scores are ≤ 0-2.
6. The age of patient is ≥ 18 years old; And the patients are premenopausal females.
7. The patients are disposed to practice contraception during the whole trial.
8. The results of patients' blood tests are as follows:
* Hb ≥ 90 g/L
* WBC ≥ 4.0×109/L
* Plt ≥ 100×109/L
* Neutrophils ≥ 1.5×109/L
* ALT and AST ≤ triple of normal upper limit.
* TBIL ≤ 1.5 times of normal upper limit.
* Creatinine ≤ 1.25 times of normal upper limit.
Exclusion Criteria:
1. The patients have other cancers at the same time or have the history of other cancers in recent five years, excluding the controlled skin basal cell carcinoma or skin squamous cell carcinoma or carcinoma in situ of cervix.
2. The patients have active infections that were not suitable for chemotherapy.
3. The patients have severe non-cancerous diseases.
4. The patients are undergoing current administration of anti-cancer therapies, or are attending some other clinical trails.
5. The patients whose breast cancers are HER2 positive and choose to undergo the neoadjuvant chemotherapy that includes herceptin regimen.
6. The patients are pregnant or lactational, or they refuse to practice contraception during the whole trial.
7. The patients are in some special conditions that they can't understand the written informed consent, such as they are demented or hawkish.
8. The patients have allergic history of the chemotherapeutic agents.
9. The patients have bilateral breast cancers.
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT01503905
Study Brief:
Protocol Section:
NCT01503905