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

• Sponsor: Ruijin Hospital (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT03907800
• Collaborator: (none)
• Enrollment: 100
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 42
• Patients Per Site Per Month: 2.4

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Breast Cancer; Triple Negative Breast Cancer; HER2-positive Breast Cancer	Drug: Nab-paclitaxel; Drug: Carboplatin; Drug: Herceptin	Phase 2

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 100 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Neoadjuvant Nab-paclitaxel in Triple-negative or HER2-positive Breast Cancer
• Actual Study Start Date: Apr 1, 2019
• Anticipated Primary Completion Date: Oct 1, 2022
• Anticipated Study Completion Date: Oct 1, 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Pathological complete response (ypT0/is ypN0) rate [16 weeks (at the time of definitive surgery)]

   Absence of invasive cancer in the breast and axillary nodes, irrespective of ductal carcinoma in situ.

Secondary Outcome Measures

1. Invasive disease-free survival (IDFS) [5 years]

   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)

2. Distant disease-free survival (DDFS) [5 years]

   DDFS is defined as the time period between registration and first event (distant recurrence, death attributable to any cause, second primary nonbreast invasive cancer)

3. Objective response rate (ORR) [16 weeks (at the time of definitive surgery)]

   ORR includes all patients whose cancer has a partial or complete response according to RECIST 1.1

4. Breast conservation rate [16 weeks (at the time of definitive surgery)]

   To determine the breast conservation rate after neoadjuvant treatment.

5. Tolerability and safety: number of patients whose treatment had to be reduced, delayed or permanently stopped [during treatment (16 weeks)]

   Descriptive statistics will be given on the number of patients whose treatment had to be reduced, delayed or permanently stopped.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ruijin Hospital	Shanghai		China	200025

Sponsors and Collaborators

• Ruijin Hospital

Investigators

• Principal Investigator: Li Zhu, Prof., Ruijin Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Li Zhu, Professor, Ruijin Hospital
• ClinicalTrials.gov Identifier: NCT03907800
• Other Study ID Numbers: RJBC1801
• First Posted: Apr 9, 2019
• Last Update Posted: Mar 10, 2020
• Last Verified: Mar 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Breast Neoplasms; Triple Negative Breast Neoplasms; Paclitaxel; Carboplatin; Trastuzumab

Study Results

No Results Posted as of Mar 10, 2020