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Association details:
| Biomarker: | HER-2 amplification |
|---|---|
| Cancer: | HER2 Positive Breast Cancer |
| Drug: | Herceptin (trastuzumab) (HER2 inhibitor) + Perjeta (pertuzumab) (HER2 dimerization inhibitor) |
| Direction: | Sensitive |
Evidence:
Source:
Title:
Preoperative Study With Trastuzumab, Pertuzumab and Letrozole in Breast Cancer Patients Sensitive to Hormonal Therapy
Excerpt:
...- HR positivity (ER ≥ 10% and/or PgR ≥10%) and HER2 positivity (IHC 3+ or FISH/CISH amplification), as assessed by local laboratory....
Trial ID:
Source:
Title:
The Use of FES-PET Imaging as a Tool to Detect a Possible Reversion of Estrogen Receptor (ER)-α Status in Patients With Metastatic Breast Cancer HER2 + and ERα Neg Treated With Trastuzumab + Pertuzumab + Taxane.
Excerpt:
...Patient with metastatic breast cancer HER2 + (IHC+++ and/or HER2 amplification in ISH according to ASCO recommendations), ERα neg (0% in IHC) and Progesterone Receptor neg (0% in IHC)....
Trial ID:
More C2 evidence
Source:
Title:
Paclitaxel, Trastuzumab, and Pertuzumab in the Treatment of Metastatic HER2-Positive Breast Cancer
Excerpt:
...- Histologically documented HER2 (+) breast cancer as defined as IHC 3+ or FISH amplification of ≥ 2.0 of primary or metastatic site; results from the local lab are acceptable....
Trial ID:
Source:
Title:
Markers to Evaluate the Efficacy of PH-based Regimen as a Neoadjuvant Therapy for Operable HER2 Positive Breast Cancer
Excerpt:
...HER2-positive disease was defined as follows: disease which overexpresses HER-2 by immunohistochemistry (IHC) 3+ and/or has HER2 amplification according to fluorescence in situ hybridization (FISH)....
Trial ID:
Source:
Title:
Phase 2 Trial of Pertuzumab and Trastuzumab With Weekly Paclitaxel and Chemotherapy for HER2 Positive Breast Cancer
Excerpt:
...HER2 overexpression or amplification will be based on local test results and is defined as either: (i) IHC staining of 3+ (uniform, intense membrane staining) in greater than or equal to 10% of invasive tumor cells or, (ii) Fluorescent in situ hybridization (FISH) result of more than six HER2 gene copies per nucleus or, (iii) FISH ratio (HER2 gene signals to chromosome 17 signals) of greater than or equal to 2.0....
Trial ID:
Source:
Title:
Imaging With 111 Indium (111In)-Pertuzumab (PmAb) to Predict Response to Trastuzumab (TmAb) in Human Epidermal Growth Factor-2 (HER2) Positive Metastatic Breast Cancer (MBC) or Locally Advanced Breast Cancer (LABC)
Excerpt:
...Tumour HER2 positive by immunohistochemistry for HER2 protein over-expression or by Fluorescence in situ Hybridization (FISH) for HER2 gene amplification, as defined by American Society of Clinical Oncology/College of American Pathologists guidelines 3....
Trial ID:
Source:
Title:
Study in Participants With Early-Stage or Locally Advanced Human Epidermal Growth Factor Receptor (HER) 2-Positive Breast Cancer to Evaluate Treatment With Trastuzumab Plus (+) Pertuzumab + Docetaxel Compared With Trastuzumab + Placebo + Docetaxel
Excerpt:
...- HER2-positive breast cancer confirmed by a Sponsor-designated central laboratory and defined as 3+ score by immunohistochemistry in > 10 percent (%) of immunoreactive cells or HER2 gene amplification (ratio of HER2 gene signals to centromere 17 signals equal to or more than [>=] 2.0) by in situ hybridization...
Trial ID:
Source:
Title:
Neoadjuvant Chemotherapy in HER2 Positive Breast Cancer, TRAIN-2
Excerpt:
...- Overexpression and/or amplification of HER2 in an invasive component of the core biopsy, according to one of the following definitions: •>30% of invasive tumor cells showing strong complete circumferential membrane staining (score 3+) •HER2 gene amplification defined as >6 HER2 gene copies per nucleus by in situ hybridization....
Trial ID:
Source:
Title:
Pertuzumab, Trastuzumab, and Paclitaxel Albumin-Stabilized Nanoparticle Formulation in Treating Patients With HER2-Positive Advanced Breast Cancer
Excerpt:
...- Tumor positive or negative for expression of hormone receptors ( 1%) and overexpressing HER2 by immunohistochemistry (IHC) (3+), or, HER2-amplified by fluorescence in situ hybridization (FISH) or by alternative gene testing...
Trial ID:
Source:
Title:
Neoadjuvant TCHP Versus THP in Patients With HER2-positive Breast Cancer (neoCARHP Study)
Excerpt:
...HER2-positive breast cancer scored as 3+ by immunohistochemistry (IHC) in > 10% of immunoreactive cells, or HER2 gene amplification (ratio of HER2 gene signals to centromere 17 signals ≥2.0) by in situ hybridization (ISH)....
Trial ID:
Source:
Title:
EC-THP Versus TCbHP in HER2-positive Lymph Node Positive Early Breast Cancer
Excerpt:
...- Early breast cancer, pathologically confirmed as HER2 positive; HER2 positive definition: Immunohistochemical HER2 3+ or FISH/CISH test positive (with amplification) is defined as HER2 positive；...
Trial ID:
Source:
Title:
A Multicenter, Randomized, Open, Phase III Trial of ddEC-THPvs Evaluating the Efficacy and Safety of TCHP Neoadjuvant Therapy for HER2-positive Breast Cancer
Excerpt:
...HER-2 positive breast cancer, defined as immunohistochemical (IHC) detection of 3+ or in situ hybridization (FISH) results of HER2 gene amplification; 4....
Trial ID:
Source:
Title:
Neoadjuvant Therapy in Clinical Stage I-III HER2-positive Breast Cancer.
Excerpt:
...HER2+, defined by either IHC 3+ or amplification of the HER2 gene by FISH analysis (ratio >2.0 or >6 HER2 targets per cell; patients with equivocal HER2 testing, 2+ by IHC with a FISH ratio of 1 cm in maximum dimension are histologically similar and HER2+....
Trial ID:
Less C2 evidence
Source:
Title:
P55: The Degree of HER2 Protein Overexpression and Gene Amplification is Associated with the Extent of Response to Neoadjuvant Therapy
Published date:
08/17/2020
Excerpt:
For patients with HER2+ breast cancer who undergo NAT, the degree of HER2 protein overexpression and gene amplification were associated with response to NAT.
Source:
Title:
Cancer Clinical Trial Versus Real-World Outcomes for Standard of Care First-Line Treatment in the Advanced Disease Setting
Published date:
08/06/2020
Excerpt:
...patients receiving a standard first line treatment for metastatic HER2‐amplified breast cancer (mHER2B) (docetaxel, trastuzumab + pertuzumab, n = 64)...Median progression free survival (PFS) for registry patients was slightly better for mCRPC (+2.7 months), mCRC (+1.1 months), and mHER2B (+4.7 months).
Secondary therapy:
docetaxel
DOI:
10.1111/ajco.13417
Source:
Title:
Pathological complete response rates in HER2 amplified breast cancers based on levels of HER2 amplification.
Published date:
05/28/2020
Excerpt:
There was found to be a statistically significant association between the level of HER2 amplification and PCR rates with increased amplification of HER2 relates with increased PCR rates (p value < 0.0176).
DOI:
10.1200/JCO.2020.38.15_suppl.e12632
Source:
Title:
7P - Prognostic value of the immune infiltration score in early breast cancer patients receiving dual HER2 blockade with trastuzumab and pertuzumab: An exploratory analysis of a randomized clinical trial
Published date:
05/23/2020
Excerpt:
Among the 162 women included in the analysis (median [range] age, 49.0 [27-81] years), the pathologic complete response (pCR) rate was 50.0% (21/42) in patients with a high IIS (>0.628) and 66.7% (80/120) in patients with a low SII (≤0.628). At a median follow-up of 4.7 years, the multivariable-adjusted hazard ratio for EFS was 2.933 (95%CI, 1.223-7.033) for the high IIS and 0.356 (95%CI, 0.127- 0.999) in patients who achieved pCR, respectively.
Trial ID:
