Efficacy and Safety of TAC and Exemestane as Neoadjuvant Chemotherapy in the Postmenopausal Women With Breast Cancer

Tianjin Medical University

Status and phase: Unknown; Phase 3; Phase 2

Conditions: Breast Cancer

Treatments: Drug: Exemestane

Study type: Interventional

Funder types: Other

Identifiers

NCT01648608

TENBC

Details and patient eligibility

About

Select the postmenopausal patients with breast cancer who is confirmed by core needle biopsy and at the clinical stage T2-4N0-2M0.Treat them with 4 cycles of TAC as neoadjuvant chemotherapy (Docetaxel was 75mg/m2, the EPI 60mg/m2 and the CTX 600mg/m2,21day/cycle).At the same time give daily oral exemestane 25mg for 12 weeks.Then assess the efficacy and safety of TAC and Exemestane.

Full description

The investigators select the postmenopausal patients with breast cancer who is confirmed by core needle biopsy and at the clinical stage T2-4N0-2M0.Treat them with 4 cycles of TAC as neoadjuvant chemotherapy (Docetaxel was 75mg/m2, the EPI 60mg/m2 and the CTX 600mg/m2,21day/cycle).At the same time give daily oral exemestane 25mg for 12 weeks.Then assess the efficacy and safety of TAC and Exemestane.

Enrollment: 600 estimated patients

Sex: Female

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Karnofsky ≥ 70

2. Provision of informed consent

3. Pathological confirmation of invasive ductal carcinoma and estrogen receptor is positive

4. Tumor stage(TNM):T2-4bN0-3M0

5. Premenopausal woman

6. Not previously received treatment with bisphosphonate

7. Laboratory criteria:

   • PLT ≥ 100*109/L
   • WBC ≥ 4000/mm3
   • HGB ≥ 10g/dl
   • GOT,GPT,ALP ≤ 2*ULN
   • TBIL,DBIL,CCr ≤ 1.5*ULN

Exclusion criteria

1. Pregnant or lactation woman
2. History of organ transplantation
3. With mental disease
4. With severe infection or active gastrointestinal ulcers
5. With severe liver disease (such as cirrhosis), kidney disease, respiratory disease or diabetes
6. Disease-free period of other malignant tumor is less than 5 years(except cured basal cell skin cancer and cervical carcinoma in situ)
7. With heart disease
8. Experimental drug allergy

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

600 participants in 1 patient group

Exemestane

Experimental group

Description:

Exemestane for neoadjuvant chemotherapy

Treatment:

Drug: Exemestane