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DISEASE & TREATMENT SETTING

Herceptin Hylecta: Breast cancer with HER2 stated without a specific alteration (adjuvant) after prior therapy

Source-derived catalogue. This is not a treatment recommendation or a personalised trial match.

Exact scope

1.1 Adjuvant Breast Cancer HERCEPTIN HYLECTA is indicated for adjuvant treatment of adults with HER2 overexpressing node positive or node negative (ER/PR negative or with one high risk feature [see Clinical Studies (14.1) ] ) breast cancer: as part of a treatment regimen consisting of doxorubicin, cyclophosphamide, and either paclitaxel or docetaxel as part of a treatment regimen with docetaxel and carboplatin as a single agent following multi-modality anthracycline based therapy.

Broader topic: Breast Cancer

Source population
Not part of this definition
Disease extent
Not part of this definition
Treatment line
adjuvant
Stage
Not part of this definition
Resectability
Not part of this definition
Biomarkers, prior therapy and derivation
molecular
  1. gene
    HER2
    alteration
    stated without a specific alteration
    status
    present
prior therapy
  1. class
    following multi-modality anthracycline based therapy
    status
    required
derivation status
source-attested
derivation note
Scoped from the FDA approved indication for Herceptin Hylecta (product label). Only dimensions stated in that wording are part of this definition.
source wording
1.1 Adjuvant Breast Cancer HERCEPTIN HYLECTA is indicated for adjuvant treatment of adults with HER2 overexpressing node positive or node negative (ER/PR negative or with one high risk feature [see Clinical Studies (14.1) ] ) breast cancer: as part of a treatment regimen consisting of doxorubicin, cyclophosphamide, and either paclitaxel or docetaxel as part of a treatment regimen with docetaxel and carboplatin as a single agent following multi-modality anthracycline based therapy.

Study evidence for this setting

59 linked studies · Applicability is a draft source assessment, not a determination of your eligibility.

NCT00021255 · Source cited / selected · Scope: unclear

Combination Chemotherapy With or Without Trastuzumab in Treating Women With Breast Cancer

3 outcome links · 3 safety-group records · 0 quality-of-life measures

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NCT00045032 · Source cited / selected · Scope: unclear

Herceptin (Trastuzumab) in Treating Women With Human Epidermal Growth Factor Receptor (HER) 2-Positive Primary Breast Cancer

6 outcome links · 3 safety-group records · 0 quality-of-life measures

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NCT00513292 · Source cited / selected · Scope: unclear

Combination Chemotherapy and Paclitaxel Plus Trastuzumab in Treating Women With Palpable Breast Cancer That Can Be Removed by Surgery

6 outcome links · 2 safety-group records · 0 quality-of-life measures

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NCT00542451 · Source cited / selected · Scope: unclear

Adjuvant Paclitaxel and Trastuzumab for Node-Negative HER2-Positive Breast Cancer

5 outcome links · 1 safety-group records · 0 quality-of-life measures

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NCT00545688 · Source cited / selected · Scope: unclear

A Study of Pertuzumab in Combination With Herceptin in Patients With HER2 Positive Breast Cancer.

6 outcome links · 4 safety-group records · 0 quality-of-life measures

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NCT00567190 · Source cited / selected · Scope: unclear

A Study to Evaluate Pertuzumab + Trastuzumab + Docetaxel vs. Placebo + Trastuzumab + Docetaxel in Previously Untreated HER2-Positive Metastatic Breast Cancer

6 outcome links · 3 safety-group records · 1 quality-of-life measures

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NCT00829166 · Source cited / selected · Scope: unclear

A Study of Trastuzumab Emtansine Versus Capecitabine + Lapatinib in Participants With HER2-positive Locally Advanced or Metastatic Breast Cancer

6 outcome links · 3 safety-group records · 2 quality-of-life measures

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NCT00861705 · Source cited / selected · Scope: unclear

Paclitaxel With or Without Carboplatin and/or Bevacizumab Followed by Doxorubicin and Cyclophosphamide in Treating Patients With Breast Cancer That Can Be Removed by Surgery

6 outcome links · 4 safety-group records · 0 quality-of-life measures

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NCT00950300 · Source cited / selected · Scope: unclear

A Study to Compare Subcutaneous (SC) Versus Intravenous (IV) Administration of Herceptin (Trastuzumab) in Women With Human Epidermal Growth Factor Receptor (HER) 2-Positive Early B

6 outcome links · 2 safety-group records · 0 quality-of-life measures

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NCT00976989 · Source cited / selected · Scope: unclear

A Study of Pertuzumab in Combination With Herceptin and Chemotherapy in Participants With HER2-Positive Breast Cancer

6 outcome links · 3 safety-group records · 0 quality-of-life measures

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NCT01007942 · Source cited / selected · Scope: unclear

Daily Everolimus in Combination With Trastuzumab and Vinorelbine in HER2/Neu Positive Women With Locally Advanced or Metastatic Breast Cancer

6 outcome links · 2 safety-group records · 1 quality-of-life measures

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NCT01037790 · Registry condition search · Scope: unclear

Phase II Trial of the Cyclin-Dependent Kinase Inhibitor PD 0332991 in Patients With Cancer

1 outcome links · 5 safety-group records · 0 quality-of-life measures

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NCT01120184 · Source cited / selected · Scope: unclear

A Study of Trastuzumab Emtansine (T-DM1) Plus Pertuzumab/Pertuzumab Placebo Versus Trastuzumab [Herceptin] Plus a Taxane in Participants With Metastatic Breast Cancer (MARIANNE)

6 outcome links · 3 safety-group records · 8 quality-of-life measures

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NCT01272037 · Source cited / selected · Scope: unclear

Tamoxifen Citrate, Letrozole, Anastrozole, or Exemestane With or Without Chemotherapy in Treating Patients With Invasive RxPONDER Breast Cancer

6 outcome links · 2 safety-group records · 2 quality-of-life measures

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NCT01358877 · Source cited / selected · Scope: unclear

A Study of Pertuzumab in Addition to Chemotherapy and Trastuzumab as Adjuvant Therapy in Participants With Human Epidermal Growth Receptor 2 (HER2)-Positive Primary Breast Cancer

6 outcome links · 2 safety-group records · 11 quality-of-life measures

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NCT01401166 · Source cited / selected · Scope: unclear

Participant Preference of Subcutaneous (SC) Versus Intravenous (IV) Herceptin (Trastuzumab) in Human Epidermal Growth Factor Receptor (HER) 2-Positive Early Breast Cancer

6 outcome links · 10 safety-group records · 0 quality-of-life measures

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NCT01419197 · Source cited / selected · Scope: unclear

A Study of Trastuzumab Emtansine in Comparison With Treatment of Physician's Choice in Participants With HER2-positive Breast Cancer Who Have Received at Least Two Prior Regimens o

6 outcome links · 3 safety-group records · 2 quality-of-life measures

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NCT01566721 · Source cited / selected · Scope: unclear

A Safety and Tolerability Study of Assisted and Self-Administered Subcutaneous (SC) Herceptin (Trastuzumab) as Adjuvant Therapy in Early Human Epidermal Growth Factor Receptor 2 (H

6 outcome links · 4 safety-group records · 0 quality-of-life measures

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NCT01740427 · Source cited / selected · Scope: unclear

A Study of Palbociclib (PD-0332991) + Letrozole vs. Letrozole For 1st Line Treatment Of Postmenopausal Women With ER+/HER2- Advanced Breast Cancer (PALOMA-2)

6 outcome links · 2 safety-group records · 2 quality-of-life measures

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NCT01772472 · Source cited / selected · Scope: unclear

A Study of Trastuzumab Emtansine Versus Trastuzumab as Adjuvant Therapy in Patients With HER2-Positive Breast Cancer Who Have Residual Tumor in the Breast or Axillary Lymph Nodes F

6 outcome links · 2 safety-group records · 2 quality-of-life measures

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Source relationships and population-mapping limitations
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      Preserved source evidence · Not medical advice