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Association details:
Evidence:
Evidence Level:
Sensitive: C2 – Inclusion Criteria
Title:

A phase II open label, multicenter study to evaluate the efficacy and safety of daily dose of Lapatinib in advanced breast cancer patients with HER-2 non-amplified primary tumours and HER-2 positive circulating tumour cells or EGFR positive circulating tumor cells

Excerpt:
...Histologically confirmed diagnosis of HER-2 negative (i.e. no gene amplification by FISH or IHC 2+ and no amplification by FISH or IHC 0/1+) infiltrating primary breast cancer. ...
Evidence Level:
Sensitive: C2 – Inclusion Criteria
Title:

Lapatinib in Women With Metastatic Breast Cancer Who Have Failed Prior Antihormone Therapy

Excerpt:
...- Primary tumor was HER-2 negative (IHC 0 or IHC 1+/2+ and Fluorescence in situ hybridization [FISH] ≤ 1.9)...
Trial ID:
More C2 evidence
Evidence Level:
Sensitive: C2 – Inclusion Criteria
Title:

Study of Lapatinib in Breast Cancer Patients With HER-2 Non-amplified Primary Tumors and HER-2 Positive or EGFR Positive Circulating Tumor Cells

Excerpt:
...- Female patients at least 18 years old with HER-2 negative breast cancer....
Trial ID:
Evidence Level:
Sensitive: C2 – Inclusion Criteria
Title:

Lapatinib Pre-Surgical Phase 2 Study in Patients with Primary Breast Cancer

Excerpt:
...All patients will be erbB2 negative.-Patients must have measurable breast cancer, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as >20 mm with conventional techniques or as >10mm with ultrasound.-No prior chemotherapy for breast cancer if given less than two years ago.- Age > or = to 18 years.- Life expectancy of greater than 12 weeks--ECOG performance status 2- Patients must have normal organ and marrow function as defined in the protocol.- Cardiac ejection fraction within the institutional range of normal as measured by echocardiogram.- Eligibility of patients receiving medications or substances known to affect, or with the potential to affect the activity or pharmacokinetics of Lapatinib will be determined following review of their use by the Principal Investigator.- Women of child-bearing potential must agree to use adequate contraception prior to study entry and for the duration of study participation.- Able to give written informed consent.- Able to swallow and retain oral medication....
Evidence Level:
Sensitive: C2 – Inclusion Criteria
Title:

Pilot Study of Veliparib (ABT-888) and Lapatinib (Tykerb) in Patients With Metastatic, Triple Negative Breast Cancer

Excerpt:
...- Tumor must be HER-2 negative, and estrogen and progesterone receptors negative....
Trial ID:
Less C2 evidence
Evidence Level:
Sensitive: C3 – Early Trials
Source:
Title:

Apatinib combined with chemotherapy versus single chemotherapy in HER-2 negative advanced breast cancer: A randomized, controlled, open-label phase II study

Published date:
05/26/2022
Excerpt:
Median PFS was significantly longer in A+CT than in CT (182 days vs 63 days; P = 0.043);The median PFS of TNBC subgroup (11 in A+CT group, 14 in CT) was longer in the aptinib group than in CT group (167 days vs 63 days; P = 0.637);The median PFS of HR+ subgroup(25 in apatinib group, 20 in chemotherapy group) was longer in the aptinib group than in CT group (259 days vs 56 days; P = 0.054);The median PFS of patients with liver metastases(19 in apatinib group, 17 in chemotherapy group) was longer in the aptinib group than in the CT group (151 days vs 54 days; P = 0.191)...Apatinib combined with chemotherapy showed a significant improvements in PFS and a manageable safety profile in HER2 negative MBC.
Secondary therapy:
Chemotherapy
DOI:
10.1200/JCO.2022.40.16_suppl.1072
Evidence Level:
Sensitive: C3 – Early Trials
Title:

A Phase II, Single-Arm Study of Apatinib and Oral Etoposide in Heavily Pre-Treated Metastatic Breast Cancer

Published date:
03/15/2021
Excerpt:
Apatinib combined with etoposide capsules is effective and tolerable in heavily pretreated, metastatic HER2-negative breast cancer patient.
Secondary therapy:
etoposide oral
DOI:
10.3389/fonc.2020.565384
Evidence Level:
Sensitive: C3 – Early Trials
Source:
Title:

Apatinib plus vinorelbine: A novel combination of all-oral regimen in heavily pretreated patients with metastatic HER2-negative breast cancer.

Published date:
05/16/2018
Excerpt:
This single arm prospective study enrolled patients with HER2 negative advanced breast cancer...Patients were treated with apatinib 500/425 mg daily plus oral vinorelbine 60-80 mg/m2 day1,8,15, q3W….Of all 40 patients, median PFS was 5.2 months (95% CI, 3.7-6.7). 31 patients were eligible for efficacy analysis. ORR was 16.1% (5/31). CBR was 38.7% (12/31)....The all-oral therapy of apatinib plus vinorelbine presented objective efficacy in heavily pretreated advanced HER2-negative breast cancer...
Secondary therapy:
vinorelbine tartrate
DOI:
10.1200/JCO.2018.36.15_suppl.e13096
Trial ID: