Neoadjuvant Nab-paclitaxel in Triple-negative or HER2-positive Breast Cancer

Breast Cancer Clinical Trial

— NeoPATH  

Official title:

Neoadjuvant Nab-paclitaxel in Triple-negative or HER2-positive Breast Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03907800
• Other study ID #: RJBC1801
• Status: Recruiting
• Phase: Phase 2
• Start date: April 1, 2019
• Est. completion date: October 2022

Study information

• Verified date: October 2022
• Source: Ruijin Hospital
• Contact: Jiayi Wu, Dr.
• Phone: 0086-21-64370045
• Email: pinkscorpio[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To evaluate the efficacy and safety of nab-paclitaxel combined with carboplatin for Chinese patients with triple-negative and HER2-positive breast cancer in the neoadjuvant setting.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: October 2022
• Est. primary completion date: October 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Written informed consent for all study according to local regulatory requirements prior to beginning specific protocol procedures.

2. Age at diagnosis = 18 years, female.

3. Histologically confirmed diagnosis of HER2-opsitive or triple-negative breast cancer. ER/PR-negativity is defined as =1% stained cells; HER2-positivity is defined as IHC 3+ or in-situ hybridisation (ISH) ratio >2.0.

4. cT2-4NanyM0 or cTanyN1-3M0

5. ECOG = 1, LVEF = 55%.

6. Laboratory requirements: for hematology, absolute neutrophil count (ANC) = 1.5 × 109 / L and platelets = 100 × 109 / L and hemoglobin = 90 g/L; for hepatic function, total bilirubin = 1.5 × UNL, AST and ALT = 2.5 × UNL; for renal function, SCr = 1.5 × UNL

7. Patients must be available and compliant for treatment and follow-up.

Exclusion Criteria:

1. Prior chemotherapy, endocrine therapy or radiation therapy for any malignancy.

2. Known or suspected congestive heart failure (> NYHA I)

3. Currently active infection or severe symptomatic visceral disease.

4. Definite contraindications for the use of corticosteroids or known hypersensitivity reaction to one of the compounds or incorporated substances used in this protocol

5. rior malignancy with a disease-free survival of < 5 years, except curatively treated basalioma of the skin, pTis of the cervix uteri.

6. Participation in another clinical trial with any investigational, not marketed drug within 30 days prior to study entry.

7. Pregnant or lactating patients. Patients of childbearing potential must implement adequate non-hormonal contraceptive measures (barrier methods, intrauterine contraceptive devices, sterilization) during study treatment.

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• HER2-positive Breast Cancer
• Triple Negative Breast Cancer
• Triple Negative Breast Neoplasms

Intervention

Drug:
• Nab-paclitaxel
125 mg/m² weekly, infusion, 3 weeks on 1 week off, applicated for four cycles.
• Carboplatin
AUC 2, weekly, 3 weeks on 1 week off, applicated for 4 cycles
• Herceptin
In case of HER2-positive, patients receive Herceptin weekly during all cycles.

Locations

Country	Name	City	State
China	Ruijin Hospital	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Ruijin Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pathological complete response (ypT0/is ypN0) rate	Absence of invasive cancer in the breast and axillary nodes, irrespective of ductal carcinoma in situ.	16 weeks (at the time of definitive surgery)
Secondary	Invasive disease-free survival (IDFS)	IDFS is defined as the time period between registration and first event (ipsilateral invasive breast tumor recurrence, regional invasive breast cancer recurrence, distant recurrence, death attributable to any cause, contralateral invasive breast cancer, second primary nonbreast invasive cancer)	5 years
Secondary	Distant disease-free survival (DDFS)	DDFS is defined as the time period between registration and first event (distant recurrence, death attributable to any cause, second primary nonbreast invasive cancer)	5 years
Secondary	Objective response rate (ORR)	ORR includes all patients whose cancer has a partial or complete response according to RECIST 1.1	16 weeks (at the time of definitive surgery)
Secondary	Breast conservation rate	To determine the breast conservation rate after neoadjuvant treatment.	16 weeks (at the time of definitive surgery)
Secondary	Tolerability and safety: number of patients whose treatment had to be reduced, delayed or permanently stopped	Descriptive statistics will be given on the number of patients whose treatment had to be reduced, delayed or permanently stopped.	during treatment (16 weeks)