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

Study to Assessment the Efficacy and Safety of Joint TAC and Exemestane as Neoadjuvant Chemotherapy in the Postmenopausal Women With Operable Breast Cancer

Status

UNKNOWN

Phases

Phase 2Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01648608

Enrollment

600

Registered

2012-07-24

Start date

2012-01-31

Completion date

2013-12-31

Last updated

2012-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

Brief summary

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.

Detailed 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.

Interventions

DRUGExemestane

Exemestane for neoadjuvant chemotherapy

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

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

Design outcomes

Primary

Measure	Time frame	Description
therapeutic assessment	6 months	therapeutic assessment

Secondary

Measure	Time frame	Description
Adverse reactions and disease-free survival	2 years	Adverse reactions and disease-free survival

Other

Measure	Time frame	Description
Recurrence or death	5 years	Recurrence or death

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026