A Phase 2 interventional study of Doxorubicin and Cyclophosphamide in Breast Cancer and Invasive Breast Cancer, sponsored by National Cancer Center, Korea. Status unknown at 1 site in Korea, Republic of. Open to female participants aged 19 Years to 70 Years. Per ClinicalTrials.gov, last updated 2018-04-13.
Sponsored by National Cancer Center, Korea · Phase 2, Interventional, and Treatment
This is an exploratory interventional study that initiates chemotherapy with letrozole in patients with estrogen receptor positive/HER2-negative breast cancer preoperably.
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.
Exclusion Criteria:
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
Drug: Doxorubicin · Drug: Cyclophosphamide · Drug: Docetaxel · Drug: Letrozole · Drug: leuprorelin
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)
pCR defined as no invasive residuals in breast and lymph nodes (ypT0/Tis, ypN0 \[MD Anderson definition\])
Time frame: within 6 weeks following the last dose of chemotherapy
Adverse events
Frequency and severity of hematological and non-hematological adverse events and laboratory abnormalities according to Common Terminology Criteria for Adverse Events (CTCAE) v4.0
Time frame: during 6 months of neoadjuvant chemotherapy
Response rate
Overall objective clinical response rate = CR + PR rate, measured by MRI (or US) and assessed by RECIST criteria.
Time frame: during 6 months of neoadjuvant chemotherapy
Downstaging to breast conserving surgery (BCS)
Ratio of the number of patients with breast conserving surgery converted from planned mastectomy over the number of patients with initially planned mastectomy
Time frame: within 6 weeks following the last dose of chemotherapy
Disease free survival
Disease-free survival (DFS) following operation.
Time frame: Patients will be followed up to 6 years
Plan to share: Undecided
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This study is status unknown, as verified in Apr 2018. You cannot join it, but the record below documents what was studied.
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National Cancer Center, Korea