BridgeMD
Compares treatment options for Breast Cancer
Official title Neoadjuvant Endocrine Therapy Versus Chemotherapy in Premenopausal Patients With ER+ & HER2- Breast Cancer
ClinicalTrials.gov ID: NCT02535221
What this study is testing
What is Goserelin+TAM+AI?
Goserelin+TAM+AI is an investigational medicine, given as an once-daily injection under the skin, being studied as a potential treatment for breast cancer.
Also referred to as Endocrine therapy.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study proposes to prove that the efficacy of adjuvant endocrine therapy for the premenopausal HR positive breast cancer patients is non-inferiority to adjuvant chemotherapy assessed by ultrasound response rate.
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 35 to 55, women only
You may be able to join if
- 35 years old \<age≤55 years old, in premenopausal status(with the judgement by researchers when the patients are recruited) Histologically confirmed...
- Stage: T2N0M0(cT\>2cm, SLNB negative), hard to proceed the breast conserving surgery(not feasible or may affect the appearance of breast)
- Histologically confirmed HR+ (ER or PR positive, and \>50% cell in IHC) HER2 negative breast cancer by pathological evaluation
- No other previous treatment for primary breast cancer
- Without other tumor or unstable complication or uncontrolled infection
You likely can't join if
- Metastasis disease by pathological or radiological diagnosis
- the history of other tumor
- contradiction for the third generation AIs, LHRHa, chemotherapy
- Contradiction for adjuvant chemotherapy: serious cardiology or cerebral vessel disease, liver or kidney disfunction, blood system disease, the other...
- Contradiction for proceeding surgery: contradiction for anesthesia, large lesion,T4, lymph node positive
- other situation not suitable for the research: psychological disease, mental disorder, social problem, geographic problem
See the full eligibility criteria
- 35 years old \<age≤55 years old, in premenopausal status(with the judgement by researchers when the patients are recruited) Histologically confirmed primary invasive breast cancer
- Stage: T2N0M0(cT\>2cm, SLNB negative), hard to proceed the breast conserving surgery(not feasible or may affect the appearance of breast)
- Histologically confirmed HR+ (ER or PR positive, and \>50% cell in IHC) HER2 negative breast cancer by pathological evaluation
- No other previous treatment for primary breast cancer
- Without other tumor or unstable complication or uncontrolled infection
- No contradiction for the third generation AIs, LHRHa, chemotherapy
- Attend the study voluntarily, sign the informed consent.
- Metastasis disease by pathological or radiological diagnosis
- the history of other tumor
- contradiction for the third generation AIs, LHRHa, chemotherapy
- Contradiction for adjuvant chemotherapy: serious cardiology or cerebral vessel disease, liver or kidney disfunction, blood system disease, the other situation or complication that are not suitable or cannot adaptable...
- Contradiction for proceeding surgery: contradiction for anesthesia, large lesion,T4, lymph node positive
- other situation not suitable for the research: psychological disease, mental disorder, social problem, geographic problem
- have been attendance in other anti-tumor treatment or other clinical trials 8) reject to attend the study
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 35 years to 55 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.