Clinical trial NCT05253066: Chidamide Combined With Exemestane (+/- Goserelin) Versus Neoadjuvant Chemotherapy in Patients of Stage II-III HR-positive/HER2-negative Breast Cancer
Official title: An Open, Multicenter, Randomized Controlled Clinical Study of Chidamide Combined With Exemestane (+/- Goserelin) Versus Neoadjuvant Chemotherapy in Patients of Stage II-III HR-positive/HER2-negative Breast Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Breast Neoplasms
Lead sponsor: Shengjing Hospital
Sponsor class: OTHER
First posted: 2022-02-23
Enrollment: 130
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is an open, multicenter, randomized controlled clinical study aimed to explore the efficacy and safety of chidamide combined with exemestane (+/- goserelin) versus chemotherapy in the neoadjuvant treatment of stage II-III HR +/HER2- breast cancer patients with poor response to previous chemotherapy.


Eligibility criteria: Inclusion Criteria:

* female patients aged greater than or equal to 18 years and less than or equal to 75 years, meet one of the following:

  1. previous oophorectomy, or age ≥ 60 years;
  2. age \< 60 years, natural postmenopausal status (defined as at least 12 consecutive months of spontaneous cessation of regular menstruation, and no other pathological or physiological causes), E2 and FSH in postmenopausal levels;
  3. premenopausal or perimenopausal female patients, must be willing to receive LHRH agonist therapy during the study;
* all patients were confirmed by histopathology as estrogen receptor (ER) positive (\> 10%), HER2 receptor negative.Follow the 2018 version of ASCO-CAP HER2-negative interpretation guideline criteria;
* tumor stage II-III meeting the AJCC 8th version criteria, patients who have previously received 2 cycles of TE regimen chemotherapy, with disease evaluation of SD or PD;
* KPS score ≥ 70 points;
* organ function level must meet the following requirements:

  1. bone marrow function ANC ≥ 1.5 × 109/L (14 without growth factors); PLT ≥ 100 × 109/L (7 without corrective treatment); Hb ≥ 100 g/L (7) without corrective treatment;
  2. liver and kidney function TBIL ≤ 1.5 × ULN; ALT and AST ≤ 3 × ULN; BUN and Cr ≤ 1.5 × ULN and creatinine clearance ≥ 50 mL/min (Cockcroft-Gault formula);
* able to undergo needle biopsy;
* voluntarily join this study, sign informed consent, have good compliance and are willing to cooperate with follow-up

Exclusion Criteria:

* received any form of anti-tumor therapy (chemotherapy, radiotherapy, molecular targeted therapy, endocrine therapy, etc.);
* received any other anti-tumor therapy at the same time;
* breast cancer, inflammatory breast cancer or occult breast cancer;
* stage IV breast cancer;
* breast cancer without histopathological diagnosis;

Primary outcomes:
measure: ORR
timeFrame: Up to approximately 48 months
Secondary outcomes:
measure: pCR：Upon completion of neoadjuvant therapy and surgery, there was no residual invasive carcinoma present in the pathologic assessment of the resected breast cancer samples stained with hematoxylin and eosin and all ipsilateral lymph node samples.
timeFrame: Up to approximately 48 months
measure: Residual tumor burden (RCB) classification
timeFrame: Up to approximately 48 months
measure: Total breast pathological complete remission rate (bpCR)
timeFrame: Up to approximately 48 months
measure: PEPI classification
timeFrame: Up to approximately 48 months
measure: Breast-conserving rate
timeFrame: Up to approximately 48 months
measure: patient-reported outcome（PRO）：evaluate daily functioning and health outcomes from the patient's perspective by HRQOL
timeFrame: Up to approximately 48 months
measure: Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
timeFrame: Up to approximately 48 months
measure: Number of participants with treatment-related serious adverse event as assessed by CTCAE v5.0
timeFrame: Up to approximately 48 months
Other outcomes:
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