Neo-adjuvant Chemotherapy With Letrozole in Patients With Estrogen Receptor Positive/HER-2 Negative Breast Cancer (NeoChAI)
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|ClinicalTrials.gov Identifier: NCT03497702|
Recruitment Status : Recruiting
First Posted : April 13, 2018
Last Update Posted : April 13, 2018
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer Invasive Breast Cancer||Drug: Doxorubicin Drug: Cyclophosphamide Drug: Docetaxel Drug: Letrozole Drug: leuprorelin||Phase 2|
STUDY RATIONALE: Patients with ER+/HER2- operable breast cancers who are candiate of neoadjuant chemotherapy generally receive chemotherapy alone before operation, followed by adjuvant endocrine therapy. Because endocrine therapy is primarily delivered in the postoperative setting, the ability to add the efficacy of aromatase inhibitors combined with chemotherapy is lost. This study offers the unique opportunity to assess the synergistic or additive responsiveness of breast tumors to endocrine therapy plus chemotherapy while the tumors are still in vivo by treating patients with an aromatast inhibitor combined with chemotherapy before surgery and assessing pCR rates.
PRIMARY OBJECTIVE: The primary objective is to determine the frequency of pCR in breast and axilla.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||114 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Study of Neo-adjuvant Chemotherapy With Letrozole in Patients With Estrogen Receptor Positive/HER-2 Negative Breast Cancer|
|Actual Study Start Date :||May 8, 2017|
|Estimated Primary Completion Date :||November 2023|
|Estimated Study Completion Date :||January 2024|
Patients receive neoadjuvant chemotherapy (doxorubicin 60mg/m2 IV and cyclophosphamide 600mg/m2 IV on day 1 every 3 weeks for 4 cycles followed by docetaxel 75mg/m2 IV on day 1 every 3 weeks for 4 cycles) plus letrozole with or without leuproelin depending on menopausal status
60mg/m2 IV every 3 weeks for 4 cycles
600mg/m2 IV every 3 weeks for 4 cycles
75mg/m2 IV every 3 weeks for 4 cycles
2.5 mg once daily preoperably
3.75 mg SC every 4 weeks for premenopausal patients
- pathologic complete remission (pCR) [ Time Frame: within 6 weeks following the last dose of chemotherapy ]pCR defined as no invasive residuals in breast and lymph nodes (ypT0/Tis, ypN0 [MD Anderson definition])
- Adverse events [ Time Frame: during 6 months of neoadjuvant chemotherapy ]Frequency and severity of hematological and non-hematological adverse events and laboratory abnormalities according to Common Terminology Criteria for Adverse Events (CTCAE) v4.0
- Response rate [ Time Frame: during 6 months of neoadjuvant chemotherapy ]Overall objective clinical response rate = CR + PR rate, measured by MRI (or US) and assessed by RECIST criteria.
- Downstaging to breast conserving surgery (BCS) [ Time Frame: within 6 weeks following the last dose of chemotherapy ]Ratio of the number of patients with breast conserving surgery converted from planned mastectomy over the number of patients with initially planned mastectomy
- Disease free survival [ Time Frame: Patients will be followed up to 6 years ]Disease-free survival (DFS) following operation.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03497702
|Contact: Keun Seok Lee, MD, PhDfirstname.lastname@example.org|
|Korea, Republic of|
|National Cancer Center||Recruiting|
|Goyang-si, Korea, Republic of|
|Contact: Keun Seok Lee, MD, PhD|
|Principal Investigator:||Keun Seok Lee, MD, PhD||National Cancer Center|