Breast CancerPhase 3GAIN-2NCT01690702
Study of Nab-Paclitaxel in High Risk Early Breast Cancer
A Phase 3 study testing Epirubicin, nab-Paclitaxel and Cyclophosphamide in people with Breast Cancer, run by GBG Forschungs GmbH at 1 site in Germany.
Trial summary
two-armed trial to compare E-nP-C against tailored dtEC-dtD in patients with high risk early breast cancer Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Epirubicin, nab-Paclitaxel and Cyclophosphamide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,886 participants
- Where
- 1 siteGermany
- Study dates
- Sep 2012to 20 Jul 2020
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Written informed consent for all study procedures according to local regulatory requirements prior to beginning specific protocol procedures.
- Histologically confirmed unilateral or bilateral primary carcinoma of the breast.
- Age at diagnosis at least 18 years, female, and biologically not older than 65 years (but in any case not older than 70 years).
- In case of adjuvant therapy: Adequate surgical treatment with histological complete resection (R0) of the invasive breast tumor. Choice of axilla surgery is up to the participating site.
- Centrally confirmed ER/PgR/HER2 and Ki-67 status detected on surgical removed tissue (for adjuvant patients) or from core biopsy (for neoadjuvant patients). ER/PR positive is defined as ≥ 1% stained cells and HER2 positive is defined as IHC 3+ in > 10% immunoreactive cells or FISH (or equivalent test) ratio ≥ 2.0. Formalin-fixed, paraffin-embedded (FFPE) breast tissue has to be sent to the Institute of Pathology at the Charité Berlin prior to randomization.
- High risk breast cancer as defined as:
Show all 25Show fewer
- HER2 positive or triple-negative tumors irrespective of nodal status or
- Luminal B-like tumors (ER and/or PgR positive, HER2 negative, Ki-67 > 20%) with involved lymph nodes or
- 4 or more involved lymph nodes.
- Complete staging work-up within 3 months prior to randomization. All patients must have performed bilateral mammography, breast ultrasound, breast MRT (optional), chest X-ray (PA and lateral), abdominal ultrasound or CT scan or MRT and bone scan. In case of positive bone scan, bone X-ray (or CT or MRT) is mandatory. Other tests may be performed as clinically indicated.
- Karnofsky Performance status index ≥ 80%.
- Estimated life expectancy of at least 10 years irrespective of the diagnosis of breast cancer.
- Confirmed normal cardiac function by ECG and cardiac ultrasound (LVEF or shortening fraction) within 2 weeks prior to randomization. LVEF must be above 55%.
- Laboratory requirements:
- Hematology
- Absolute neutrophil count (ANC) ≥ 2.0 x 109/L and
- Platelets ≥ 100 x 109/L and
- Hemoglobin ≥ 10 g/dL (≥ 6.2 mmol/L). Hepatic function
- Total bilirubin ≤ 1.5x above upper normal limits (UNL) and
- ASAT (SGOT) and ALAT (SGPT) ≤ 1.5x UNL and
- Alkaline phosphatase ≤ 2.5x UNL. Renal function Creatinine ≤ 1.25 UNL,
- Creatinine Clearance > 30mL/min (if creatinine is above UNL, according to Cockroft-Gault).
- Negative pregnancy test (urine or serum) within 14 days prior to randomization for all women of childbearing potential.
- Complete baseline documentation must be submitted via MedCODES and approved by GBG Forschungs GmbH.
- Patients must be available and compliant for central diagnostics, treatment and follow-up.
Who cannot join
- Patients with Luminal A-like tumors (ER and or PgR positive, HER2 negative and Ki-67 ≤ 20%) and
- if neoadjuvant: < cN2 or < pN2(sn).
- if adjuvant: < 4 involved lymph nodes.
- Non-operable breast cancer.
- In case of adjuvant therapy: time since axillary dissection or SLNB > 3 months (optimal < 1 month).
- Previous and already (neoadjuvant or adjuvant) treated invasive breast carcinoma.
Show all 20Show fewer
- Previous malignant disease being disease-free for less than 5 years (except CIS of the cervix and non-melanomatous skin cancer).
- Known or suspected congestive heart failure (> NYHA I) and/or coronary heart disease, angina pectoris requiring anti-anginal medication, previous history of myocardial infarction, evidence of transmural infarction on ECG, uncontrolled or poorly controlled arterial hypertension (i.e. BP > 160/90mm Hg under treatment with two antihypertensive drugs), rhythm abnormalities requiring permanent treatment, clinically significant valvular heart disease.
- Evidence for infection including wound infections, HIV, hepatitis.
- History of significant neurological or psychiatric disorders including psychotic disorders, dementia or seizures that would prohibit the understanding and giving of informed consent.
- Pre-existing motor or sensory neuropathy of a severity ≥ grade 1 by NCI-CTCAE version 4.0.
- Other severe and relevant co-morbidity that would interact with the application of cytotoxic agents or the participation in the study.
- Previous or concurrent treatment with:
- concurrent chronic corticosteroids unless initiated > 6 months prior to study entry and at low dose (≤ 10mg methylprednisolone or equivalent) except inhalative corticoids.
- concurrent sex hormones. Prior treatment must be stopped before study entry.
- concurrent treatment with any investigational, not marketed drug within 30 days prior to study entry.
- previous or concurrent anti-cancer therapy for any reason.
- Absolute contraindications for the use of corticosteroids.
- Pregnant or lactating patients. Patients of childbearing potential must implement adequate non-hormonal contraceptive measures (barrier methods, intrauterine contraceptive devices, sterilization) during study treatment.
- Known hypersensitivity reaction to one of the compounds or incorporated substances used in this protocol.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Neo-/Adjuvant Phase III Trial to Compare Intense Dose-dense Chemotherapy to Tailored Dose-dense Chemotherapy in Patients With High-risk Early Breast Cancer (GAIN-2)
two-armed trial to compare E-nP-C against tailored dtEC-dtD in patients with high risk early breast cancer
Read the detailed description
The Norton-Simon-Hypothesis on log cell kill suggests that chemotherapy should be given at maximum dosages at minimum intervals. Combination chemotherapy, which always has to make compromises regarding the doses of each drug and treatment intervals due to acute as well as cumulative toxicities, does therefore not comply with this theory. Sequential application of monotherapies, however, allows very high single agent doses and dose-dense treatment intervals. Regimens designed according to the Norton-Simon-Hypothesis have shown to be highly active as adjuvant treatment for early breast cancer. As the number of cycles of each agent can be restricted to 3, as previously done in the AGO ETC trial by Möbus et al., cumulative toxicities do not really occur.
Two large scale trials of dose-dense chemotherapy have proven very high protective activity against tumor recurrence (AGO ETC (Ref.1) and CALGB 9741 (Ref.2)). Especially the ETC trial (epirubicin, solvent-based paclitaxel, and cyclophosphamide) showed an impressive superior DFS and OS in 1284 high-risk breast cancer patients with > 4positive lymph nodes. The doses used are exceptional at maximum dosage and minimum intervals with epirubicin 150 mg/m², Paclitaxel 225 mg/m² and cyclophosphamide 2.5 g/m² given every 2 weeks based on the above described Norton-Simon-Hypothesis. However, as each drug was given only 3 times at intervals of 2 weeks, this regimen is feasible and safe with primary support of G-CSF and ESF. The ETC schedule is today considered standard of care for high-risk breast cancer patients in Germany.
However, both trials, ETC and CALGB 9741, compared the dose-dense concept against EC-P q3w which is nowadays considered to be an inferior regimen compared to EC-P weekly or EC-Doc. The GAIN trial had a 2x2 factorial design and explored ETC versus EC-TX and ibandronate vs. observation. The trial closed recruitment after 3023 pts in July 2008. In the Panther trial, a joint effort of SBG, ABCSG, AGO-B and GBG, the tailored, dose-dense EC-Doc (dtEC-dtD) regimen was tested against conventional dosed FEC-Doc. Efficacy results are to be awaited, safety results will be published in 2012.
Nab-paclitaxel (nP) provides a better toxicity profile and a higher efficacy compared to solvent based taxanes (paclitaxel and docetaxel). It might therefore be the preferred component in an intense dose-dense regimen. Assuming that the corresponding dose of nab-paclitaxel to 175 mg/m² paclitaxel is 260 mg/m², an appropriate dose would be 330 mg/m² nab-paclitaxel to substitute paclitaxel at 225 mg/m². So far, no experience with such a dose of nab-paclitaxel is available. However, initial experience with 300mg/m² q3w and 150mg/m² weekly (in 3 out of 4 weeks) showed a good safety profile even when given for a median of 8 cycles (Ref.3). Another pilot study showed a good tolerability of 260 mg/m² nab-paclitaxel given q2w for 4 cycles (Ref.4+5).
The GAIN-2 trial will allow for comparing the toxicity and effectiveness of a predefined intense dose-dense regimen (EnPC) vs. a dose-dense regimen with modification of single doses depending on individual haematological and non-haematological toxicities. The primary aim of the GAIN-2 trial will be to compare the invasive disease-free survival after adjuvant chemotherapy with EnPC or dtEC-dtD in patients with primary node-positive or high risk node negative breast cancer. To explore the maximum dose of nab-paclitaxel in this setting, a run-in phase with varying doses of nab-paclitaxel is included in the study design.
- Conditions
- Breast Cancer
- Being tested
- Epirubicin, nab-Paclitaxel, Cyclophosphamide, Docetaxel
- Keywords
- breast cancer, tailored, high-risk
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EpirubicinDrug
nab-PaclitaxelDrug
CyclophosphamideDrug
DocetaxelDrug
| Study group | Role | What they receive |
|---|---|---|
| dtEC-dtD | Active comparator | Epirubicin and Cyclophosphamide with a tailored dose 4 cycles q2w followed by one additional week followed by Docetaxel with a tailored dose 4 cycles q2w. Receives: Drug: Epirubicin; Drug: Cyclophosphamide; Drug: Docetaxel |
| EnPC | Experimental | Epirubicin 150mg/qm 3 cycles q2w followed by nabPaclitaxel 260-330mg/qm (to be determined in run-in-phase) 3 cycles q2w followed by Cyclophosphamide 2000mg/qm 3 cycles q2w Receives: Drug: Epirubicin; Drug: nab-Paclitaxel; Drug: Cyclophosphamide |
What is being measured
The primary outcome is the main question the study is designed to answer.
invasive disease-free survival (IDFS)
The IDFS is defined as the time period between the registration and the first invasive event. It will be analyzed after the end of the study by referring to data from GBG patient's registry.
Measured: 5 years
Secondary outcomes (13)
locoregional relapse-free survival (LRRFS)
The LRRFS is defined as the time period between the registration and the first locoregional event. It will be analyzed after the end of the study by referring to data from GBG patient's registry.
Measured: 5 years
overall survival (OS)
The OS is defined as the time period between the registration and the death of a patient. It will be analyzed after the end of the study by referring to data from GBG patient's registry (relatives can give the information regarding death as well).
Measured: 5 years
distant disease-free survival (DDFS)
The DDFS is defined as the time period between the registration and the first distant event. It will be analyzed after the end of the study by referring to data from GBG patient's registry.
Measured: 5 years
local relapse-free survival (LRFS)
LRFS is defined as the time period between registration and first local event and will be analyzed after the end of the study by referring to data from GBG patient's registry.
Measured: 5 years
regional relapse-free survival (RRFS)
RRFS is defined as the time period between registration and first regional event and will be analyzed after the end of the study by referring to data from GBG patient's registry.
Measured: 5 years
brain metastasis free survival (in the subgroup of TNBC and HER2+)
brain metastasis free survival is defined as the time period between registration and first brain metastasis event and will be analyzed after the end of the study by referring to data from GBG patient's registry.
Measured: 5 years
compliance
compliance is defined as the adherence to protocol and will be analyzed after the end of the therapy by referring to data from CRF.
Measured: 5 years
safety
safety is defined by the AE that occur and will be analyzed after the end of the therapy by referring to data from CRF (including time to resolve neuropathy to grade 1)
Measured: 5 years
side effects of taxane
Side effects of taxane are measured before, during and after chemotherapy by FACT-taxane questionnaires. the questionnaires will be analyzed after the end of the therapy.
Measured: 5 years
treatment effects by intrinsic subtypes
the treatment effect will be analyzed after the end of the therapy by referring to data from CRF and later by using the data from patient registry to compare the outcome in the different subtypes. The intrinsic subtypes are: 0-3, 4-9 or 10+ involved nodes as well as Ki-67.
Measured: 5 years
Ovarian substudy
To assess ovarian function measured by amenorrhea rate in correlation with changes in E2, FSH, LH , Anti-Müller Hormone, ultrasound-follicle count in patients aged <45 years.
Measured: Baseline, 6 months, 12 months, 18 months, 24 months 30 months
Pharmacogenetic substudy
To correlate Single Nucleotide Polymorphisms (SNPs) of genes with the associated toxicity and histologically assessed treatment effect.
Measured: Baseline
biology of lymph node metastases
The correlation of lymph node metastases with biological markers is investigated
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2012 (estimated)
- Study startSep 2012
- Primary completion30 Sep 2018
- Study completion20 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 2,886 participants (actual)
Sponsor and investigators
- Lead sponsor
- GBG Forschungs GmbH
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gunter von Minckwitz, Prof., Study chair, GBG Forschungs GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01690702
- Sponsor's protocol ID
- GBG 68
- Acronym
- GAIN-2
- Status last verified
- Feb 2021
- First submitted
- 29 Aug 2012
- Last updated
- 2 Feb 2021
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Denkert C, Seither F, Schneeweiss A, Link T, Blohmer JU, Just M, Wimberger P, Forberger A, Tesch H, Jackisch C, Schmatloch S, Reinisch M, Solomayer EF, Schmitt WD, Hanusch C, Fasching PA, Lubbe K, Solbach C, Huober J, Rhiem K, Marme F, Reimer T, Schmidt M, Sinn BV, Janni W, Stickeler E, Michel L, Stotzer O, Hahnen E, Furlanetto J, Seiler S, Nekljudova V, Untch M, Loibl S. Clinical and molecular characteristics of HER2-low-positive breast cancer: pooled analysis of individual patient data from four prospective, neoadjuvant clinical trials. Lancet Oncol. 2021 Aug;22(8):1151-1161. doi: 10.1016/S1470-2045(21)00301-6. Epub 2021 Jul 9.
PubMed 34252375
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neo-/Adjuvant Phase III Trial to Compare Intense Dose-dense Chemotherapy to Tailored Dose-dense Chemotherapy in Patients With High-risk Early Breast Cancer (GAIN-2)
- ClinicalTrials.gov ID
- NCT01690702
- Acronym / sponsor ID
- GAIN-2 / GBG 68
- Conditions
- Breast Cancer
- Keywords
- breast cancer, tailored, high-risk
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,886 participants (actual)
- Lead sponsor
- GBG Forschungs GmbHUniversity, hospital or other
- Collaborators
- Celgene, Amgen
- Study start
- Sep 2012
- Primary completion
- 30 Sep 2018 (actual)
- Study completion
- 20 Jul 2020 (actual)
- First posted
- 24 Sep 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
two-armed trial to compare E-nP-C against tailored dtEC-dtD in patients with high risk early breast cancer
Detailed description
The Norton-Simon-Hypothesis on log cell kill suggests that chemotherapy should be given at maximum dosages at minimum intervals. Combination chemotherapy, which always has to make compromises regarding the doses of each drug and treatment intervals due to acute as well as cumulative toxicities, does therefore not comply with this theory. Sequential application of monotherapies, however, allows very high single agent doses and dose-dense treatment intervals. Regimens designed according to the Norton-Simon-Hypothesis have shown to be highly active as adjuvant treatment for early breast cancer. As the number of cycles of each agent can be restricted to 3, as previously done in the AGO ETC trial by Möbus et al., cumulative toxicities do not really occur.
Two large scale trials of dose-dense chemotherapy have proven very high protective activity against tumor recurrence (AGO ETC (Ref.1) and CALGB 9741 (Ref.2)). Especially the ETC trial (epirubicin, solvent-based paclitaxel, and cyclophosphamide) showed an impressive superior DFS and OS in 1284 high-risk breast cancer patients with > 4positive lymph nodes. The doses used are exceptional at maximum dosage and minimum intervals with epirubicin 150 mg/m², Paclitaxel 225 mg/m² and cyclophosphamide 2.5 g/m² given every 2 weeks based on the above described Norton-Simon-Hypothesis. However, as each drug was given only 3 times at intervals of 2 weeks, this regimen is feasible and safe with primary support of G-CSF and ESF. The ETC schedule is today considered standard of care for high-risk breast cancer patients in Germany.
However, both trials, ETC and CALGB 9741, compared the dose-dense concept against EC-P q3w which is nowadays considered to be an inferior regimen compared to EC-P weekly or EC-Doc. The GAIN trial had a 2x2 factorial design and explored ETC versus EC-TX and ibandronate vs. observation. The trial closed recruitment after 3023 pts in July 2008. In the Panther trial, a joint effort of SBG, ABCSG, AGO-B and GBG, the tailored, dose-dense EC-Doc (dtEC-dtD) regimen was tested against conventional dosed FEC-Doc. Efficacy results are to be awaited, safety results will be published in 2012.
Nab-paclitaxel (nP) provides a better toxicity profile and a higher efficacy compared to solvent based taxanes (paclitaxel and docetaxel). It might therefore be the preferred component in an intense dose-dense regimen. Assuming that the corresponding dose of nab-paclitaxel to 175 mg/m² paclitaxel is 260 mg/m², an appropriate dose would be 330 mg/m² nab-paclitaxel to substitute paclitaxel at 225 mg/m². So far, no experience with such a dose of nab-paclitaxel is available. However, initial experience with 300mg/m² q3w and 150mg/m² weekly (in 3 out of 4 weeks) showed a good safety profile even when given for a median of 8 cycles (Ref.3). Another pilot study showed a good tolerability of 260 mg/m² nab-paclitaxel given q2w for 4 cycles (Ref.4+5).
The GAIN-2 trial will allow for comparing the toxicity and effectiveness of a predefined intense dose-dense regimen (EnPC) vs. a dose-dense regimen with modification of single doses depending on individual haematological and non-haematological toxicities. The primary aim of the GAIN-2 trial will be to compare the invasive disease-free survival after adjuvant chemotherapy with EnPC or dtEC-dtD in patients with primary node-positive or high risk node negative breast cancer. To explore the maximum dose of nab-paclitaxel in this setting, a run-in phase with varying doses of nab-paclitaxel is included in the study design.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| dtEC-dtD | Active comparator | Drug: Epirubicin, Drug: Cyclophosphamide, Drug: DocetaxelEpirubicin and Cyclophosphamide with a tailored dose 4 cycles q2w followed by one additional week followed by Docetaxel with a tailored dose 4 cycles q2w. |
| EnPC | Experimental | Drug: Epirubicin, Drug: nab-Paclitaxel, Drug: CyclophosphamideEpirubicin 150mg/qm 3 cycles q2w followed by nabPaclitaxel 260-330mg/qm (to be determined in run-in-phase) 3 cycles q2w followed by Cyclophosphamide 2000mg/qm 3 cycles q2w |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (25 listed)
- Written informed consent for all study procedures according to local regulatory requirements prior to beginning specific protocol procedures.
- Histologically confirmed unilateral or bilateral primary carcinoma of the breast.
- Age at diagnosis at least 18 years, female, and biologically not older than 65 years (but in any case not older than 70 years).
- In case of adjuvant therapy: Adequate surgical treatment with histological complete resection (R0) of the invasive breast tumor. Choice of axilla surgery is up to the participating site.
- Centrally confirmed ER/PgR/HER2 and Ki-67 status detected on surgical removed tissue (for adjuvant patients) or from core biopsy (for neoadjuvant patients). ER/PR positive is defined as ≥ 1% stained cells and HER2 positive is defined as IHC 3+ in > 10% immunoreactive cells or FISH (or equivalent test) ratio ≥ 2.0. Formalin-fixed, paraffin-embedded (FFPE) breast tissue has to be sent to the Institute of Pathology at the Charité Berlin prior to randomization.
Key exclusion criteria (20 listed)
- Patients with Luminal A-like tumors (ER and or PgR positive, HER2 negative and Ki-67 ≤ 20%) and
- Non-operable breast cancer.
- In case of adjuvant therapy: time since axillary dissection or SLNB > 3 months (optimal < 1 month).
- Previous and already (neoadjuvant or adjuvant) treated invasive breast carcinoma.
- Previous malignant disease being disease-free for less than 5 years (except CIS of the cervix and non-melanomatous skin cancer).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Epirubicin | Drug | EnPC, dtEC-dtD |
| nab-Paclitaxel | Drug | EnPC |
| Cyclophosphamide | Drug | EnPC, dtEC-dtD |
| Docetaxel | Drug | dtEC-dtD |
Primary outcome
invasive disease-free survival (IDFS)
Time frame: 5 years
The IDFS is defined as the time period between the registration and the first invasive event. It will be analyzed after the end of the study by referring to data from GBG patient's registry.
13 secondary outcomes
locoregional relapse-free survival (LRRFS)
Time frame: 5 years
overall survival (OS)
Time frame: 5 years
distant disease-free survival (DDFS)
Time frame: 5 years
local relapse-free survival (LRFS)
Time frame: 5 years
regional relapse-free survival (RRFS)
Time frame: 5 years
brain metastasis free survival (in the subgroup of TNBC and HER2+)
Time frame: 5 years
compliance
Time frame: 5 years
safety
Time frame: 5 years
side effects of taxane
Time frame: 5 years
treatment effects by intrinsic subtypes
Time frame: 5 years
Ovarian substudy
Time frame: Baseline, 6 months, 12 months, 18 months, 24 months 30 months
Pharmacogenetic substudy
Time frame: Baseline
biology of lymph node metastases
Time frame: baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2021.
- Derived from this study: PubMed 34252375Denkert C, Seither F, Schneeweiss A, Link T, Blohmer JU, Just M, Wimberger P, Forberger A, Tesch H, Jackisch C, Schmatloch S, Reinisch M, Solomayer EF, Schmitt WD, Hanusch C, Fasching PA, Lubbe K, Solbach C, Huober J, Rhiem K, Marme F, Reimer T, Schmidt M, Sinn BV, Janni W, Stickeler E, Michel L, Stotzer O, Hahnen E, Furlanetto J, Seiler S, Nekljudova V, Untch M, Loibl S. Clinical and molecular characteristics of HER2-low-positive breast cancer: pooled analysis of individual patient data from four prospective, neoadjuvant clinical trials. Lancet Oncol. 2021 Aug;22(8):1151-1161. doi: 10.1016/S1470-2045(21)00301-6. Epub 2021 Jul 9.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gunter von Minckwitz, Prof. study chair
GBG Forschungs GmbH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Epirubicin, nab-Paclitaxel and Cyclophosphamide in people with Breast Cancer, run by GBG Forschungs GmbH at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 25 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
invasive disease-free survival (IDFS) (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01690702, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Feb 2021.