Breast Cancer Female NOSPhase 2GeparXNCT02682693

Denosumab as an add-on Neoadjuvant Treatment (GeparX)

A Phase 2 study testing Denosumab, nab-Paclitaxel and Epirubicin in people with Breast Cancer Female NOS and Tubular Breast Cancer Stage II, run by GBG Forschungs GmbH at 1 site in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Pharmacologic inhibition of RANKL attenuates the development of mammary carcinoma and inhibits metastatic progression in multiple mouse models. In a retrospective analysis it could be demonstrated that elevated expression of RANK was found in 14.5% of patients overall, with a significant predominance in patients with… Read more about this study

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Breast Cancer Female NOS, Tubular Breast Cancer Stage II, Mucinous Breast Cancer Stage II
What is being tested?: Denosumab, nab-Paclitaxel and Epirubicin
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 780 participants
Where: 1 siteGermany
Study dates: 13 Feb 2017to 31 Dec 2020
Phase: Phase 2
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 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Unilateral or bilateral primary carcinoma of the breast, confirmed histologically by core biopsy. Fine-needle aspiration from the breast lesion alone is not sufficient. Incisional biopsy or axillary clearance is not allowed. In case of bilateral cancer, the investigator has to decide prospectively which side will be evaluated for the primary endpoint.
Tumor lesion in the breast with a palpable size of 2 cm or a sonographical size of 1 cm in maximum diameter. The lesion has to be measurable in two dimensions, preferably by sonography. In case tumor isn't measurable by sonography, then MRI or mammography is sufficient. In case of inflammatory disease, the extent of inflammation can be used as measurable lesion.
Patients must have stage cT1c - cT4a-d disease.
In patients with multifocal or multicentric breast cancer, the largest lesion should be measured.
Centrally confirmed ER-negative and PR-negative status. Central pathology includes also assessment of HER2, Ki-67, TIL and RANK status on core biopsy. ER/PR negative is defined as ≤1% stained cells and HER2-positive is defined as IHC 3+ or in-situ hybridization (ISH) and according to ASCO-CAP guidelines as of 2013. LPBC (lymphocyte predominant breast cancer) is defined as more than 50% stromal tumour infiltrating lymphocytes. Formalin-fixed, paraffin-embedded (FFPE) breast tissue from core biopsy has therefore to be sent to the GBG central pathology laboratory prior to randomization.

Who cannot join

Patients with stages cT1a, cT1b, or any M1.
Prior chemotherapy for any malignancy.
Prior radiation therapy for breast cancer.
History of disease with influence on bone metabolism, such as osteoporosis, Paget's disease of bone, primary hyperparathyroidism requiring treatment at the time of randomization or considered likely to become necessary within the subsequent six months.
Use of bisphosphonates or denosumab within the past 1 year.
Significant dental/oral disease, including prior history or current evidence of osteonecrosis/ osteomyelitis of the jaw, active dental or jaw condition which requires oral surgery, non-healed dental/oral surgery, planned invasive dental procedure for the course of the study.

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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 antianginal medication, previous history of myocardial infarction, evidence of transmural infarction on ECG, uncontrolled or poorly controlled arterial hypertension (i.e. BP >140 / 90 mm Hg under treatment with two antihypertensive drugs), rhythm abnormalities requiring permanent treatment, clinically significant valvular heart disease.
Currently active infection.
Incomplete wound healing.
Definite contraindications for the use of corticosteroids.

Trial locations and contacts

1 site in 1 country.

Germany1 site

Charité Campus Mitte
Berlin, 10113

Other trials in Germany

About this study

Official title: Investigating Denosumab as an add-on Neoadjuvant Treatment for RANK-positive or RANK-negative Primary Breast Cancer and Two Different Nab-Paclitaxel Schedules ; 2x2 Factorial Design (GeparX)

Pharmacologic inhibition of RANKL attenuates the development of mammary carcinoma and inhibits metastatic progression in multiple mouse models.

In a retrospective analysis it could be demonstrated that elevated expression of RANK was found in 14.5% of patients overall, with a significant predominance in patients with hormone-receptor-negative disease. Expression of RANK was associated with a higher pathological complete response rate but with a shorter disease-free and overall survival. The ABCSG-18 study showed that adjuvant denosumab reduces clinical fractures, improves bone health, and can be administered without added toxicity.

It appears therefore reasonable to test denosumab, a clinically available antibody against RANKL in patients with hormone-receptor-negative primary breast cancer as an adjunct to neoadjuvant chemotherapy for its ability to increase pCR rate and improve outcome in relation to the expression of RANK.

Read the detailed description

RANK ligand (RANKL), a key factor for bone remodeling and metastasis, is crucial for the development of mouse mammary glands during pregnancy. RANKL functions as a major paracrine effector of the mitogenic action of progesterone in mouse and human mammary epithelium via its receptor RANK and has a role in ovarian hormone-dependent expansion and regenerative potential of mammary stem cells. Pharmacologic inhibition of RANKL attenuates the development of mammary carcinoma and inhibits metastatic progression in multiple mouse models.

In a retrospective analysis of 601 patients treated in the GeparTrio study with chemotherapy (TAC) it could be demonstrated that elevated expression of RANK (immunohistochemical score > 8.5 using the N-1H8 antibody by Amgen) was found in 14.5% of patients overall, with a significant predominance in patients with hormone-receptor-negative disease (33.7% vs 6.4% tumors positive for RANK). Expression of RANK was associated with a higher pathological complete response rate (pCR) (23.0% vs 12.6%) but with a shorter disease-free and overall survival. The ABCSG-18 study showed that adjuvant denosumab reduces clinical fractures, improves bone health, and can be administered without added toxicity. Moreover denosumab improves disease-free survival in postmenopausal woman with hormone receptor positive breast cancer.

Conditions: Breast Cancer Female NOS, Tubular Breast Cancer Stage II, Mucinous Breast Cancer Stage II, Invasive Ductal Breast Cancer, HER2 Positive Breast Cancer, Inflammatory Breast Cancer
Being tested: Denosumab, nab-Paclitaxel, Epirubicin, Cyclophosphamide, Carboplatin
Medical subject headings: Carcinoma, Ductal, Breast, Inflammatory Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

DenosumabDrug
Also called Human monoclonal IgG2 antibody
Denosumab 120 mg every 4 weeks for 6 cycles
nab-PaclitaxelDrug
Also called Abraxane
nab-paclitaxel 125 mg/m² weekly for 12 weeks or at day 1,8 q22 for 4 cycles (12 weeks)
EpirubicinDrug
Also called Farmorubicin
Epirubicin 90 mg/m² every 2 or 3 weeks for 4 times
CyclophosphamideDrug
Also called Endoxan
Cyclophosphamide 600 mg/m² every 2 or 3 weeks for 4 times
CarboplatinDrug
Also called Diamminplatin(II)-cyclobutan-1,1-dicarboxylat
Carboplatin AUC 2 weekly in parallel to nab-Paclitaxel
TrastuzumabDrug
Also called Herceptin
Trastuzumab 6 (8) mg/kg every 3 weeks simultaneously to all chemotherapy cycles
PertuzumabDrug
Also called Perjeta
Pertuzumab 420 (840) mg every 3 weeks simultaneously to all chemotherapy cycles

Study groups in NCT02682693
Study group	Role	What they receive
Denosumab	Experimental	Denosumab every 4 weeks for 6 cycles. Receives: Drug: Denosumab
nab-Paclitaxel weekly	Experimental	nab-Paclitaxel weekly for 12 weeks. Patients with HER2-positive tumors receive Trastuzumab and Pertuzumab. Patients with triple-negative tumors receive Carboplatin in parallel to nab-paclitaxel. Receives: Drug: nab-Paclitaxel; Drug: Carboplatin; Drug: Trastuzumab; Drug: Pertuzumab
nab-paclitaxel 2 of 3 weeks	Experimental	nab-Paclitaxel day 1,8 q22 for 12 weeks. Patients with HER2-positive tumors receive Trastuzumab and Pertuzumab. Patients with triple-negative tumors receive Carboplatin weekly in parallel to nab-paclitaxel. Receives: Drug: nab-Paclitaxel; Drug: Carboplatin; Drug: Trastuzumab; Drug: Pertuzumab
EC every two weeks or every three weeks	Experimental	Epirubicin and Cyclophosphamide 600mg/m² for 4 times. Patients with HER2-positive tumors receive Trastuzumab and Pertuzumab. Receives: Drug: Epirubicin; Drug: Cyclophosphamide; Drug: Trastuzumab; Drug: Pertuzumab

What is being measured

The primary outcome is the main question the study is designed to answer.

pcR rates of neoadjuvant treatment with or without denosumab in addition to nab-paclitaxel and EC.
Measured: 24 weeks
pcR (ypT0 ypN0) rates of nab-Paclitaxel weekly for 12 weeks or 2 of 3 weeks for 12 weeks
Measured: 12 weeks

Secondary outcomes (2)

To test for interaction of denosumab treatment with RANK expression.
Measured: 24 weeks
To assess the pCR rates per arm for both randomizations separately for TNBC and HR-/HER2+ tumors.
Measured: 24 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

13 Feb 201731 Dec 2020

First posted15 Feb 2016 (estimated)
Study start13 Feb 2017
Primary completion31 Dec 2019
Study completion31 Dec 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (3)Papers the sponsor has linked to this study.
Other trials for Breast Cancer Female NOSStudies 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 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Factorial
Masking: None (open label)
Enrolment: 780 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02682693
Sponsor's protocol ID: GBG 88
Acronym: GeparX
Status last verified: Feb 2021
First submitted: 27 Jan 2016
Last updated: 2 Feb 2021
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Adams A, Jakob T, Huth A, Monsef I, Ernst M, Kopp M, Caro-Valenzuela J, Wockel A, Skoetz N. Bone-modifying agents for reducing bone loss in women with early and locally advanced breast cancer: a network meta-analysis. Cochrane Database Syst Rev. 2024 Jul 9;7(7):CD013451. doi: 10.1002/14651858.CD013451.pub2.
PubMed 38979716
Blohmer JU, Link T, Reinisch M, Just M, Untch M, Stotzer O, Fasching PA, Schneeweiss A, Wimberger P, Seiler S, Huober J, Thill M, Jackisch C, Rhiem K, Solbach C, Hanusch C, Seither F, Denkert C, Engels K, Nekljudova V, Loibl S; GBG and AGO-B. Effect of Denosumab Added to 2 Different nab-Paclitaxel Regimens as Neoadjuvant Therapy in Patients With Primary Breast Cancer: The GeparX 2 x 2 Randomized Clinical Trial. JAMA Oncol. 2022 Jul 1;8(7):1010-1018. doi: 10.1001/jamaoncol.2022.1059.
PubMed 35588050
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

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Breast Cancer Female NOS trials

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: Investigating Denosumab as an add-on Neoadjuvant Treatment for RANK-positive or RANK-negative Primary Breast Cancer and Two Different Nab-Paclitaxel Schedules ; 2x2 Factorial Design (GeparX)
ClinicalTrials.gov ID: NCT02682693
Acronym / sponsor ID: GeparX / GBG 88
Conditions: Breast Cancer Female NOS, Tubular Breast Cancer Stage II, Mucinous Breast Cancer Stage II, Invasive Ductal Breast Cancer, HER2 Positive Breast Cancer, Inflammatory Breast Cancer
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 780 participants (actual)
Lead sponsor: GBG Forschungs GmbHUniversity, hospital or other
Collaborators: Amgen, Celgene Corporation
Study start: 13 Feb 2017 (actual)
Primary completion: 31 Dec 2019 (actual)
Study completion: 31 Dec 2020 (actual)
First posted: 15 Feb 2016 (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.

Pharmacologic inhibition of RANKL attenuates the development of mammary carcinoma and inhibits metastatic progression in multiple mouse models.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Factorial
Masking: None (open label)
Number of arms: 4

Arm	Type	Receives
Denosumab	Experimental	Drug: DenosumabDenosumab every 4 weeks for 6 cycles.
nab-Paclitaxel weekly	Experimental	Drug: nab-Paclitaxel, Drug: Carboplatin, Drug: Trastuzumab, Drug: Pertuzumabnab-Paclitaxel weekly for 12 weeks. Patients with HER2-positive tumors receive Trastuzumab and Pertuzumab. Patients with triple-negative tumors receive Carboplatin in parallel to nab-paclitaxel.
nab-paclitaxel 2 of 3 weeks	Experimental	Drug: nab-Paclitaxel, Drug: Carboplatin, Drug: Trastuzumab, Drug: Pertuzumabnab-Paclitaxel day 1,8 q22 for 12 weeks. Patients with HER2-positive tumors receive Trastuzumab and Pertuzumab. Patients with triple-negative tumors receive Carboplatin weekly in parallel to nab-paclitaxel.
EC every two weeks or every three weeks	Experimental	Drug: Epirubicin, Drug: Cyclophosphamide, Drug: Trastuzumab, Drug: PertuzumabEpirubicin and Cyclophosphamide 600mg/m² for 4 times. Patients with HER2-positive tumors receive Trastuzumab and Pertuzumab.

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Unilateral or bilateral primary carcinoma of the breast, confirmed histologically by core biopsy. Fine-needle aspiration from the breast lesion alone is not sufficient. Incisional biopsy or axillary clearance is not allowed. In case of bilateral cancer, the investigator has to decide prospectively which side will be evaluated for the primary endpoint.
Tumor lesion in the breast with a palpable size of 2 cm or a sonographical size of 1 cm in maximum diameter. The lesion has to be measurable in two dimensions, preferably by sonography. In case tumor isn't measurable by sonography, then MRI or mammography is sufficient. In case of inflammatory disease, the extent of inflammation can be used as measurable lesion.
Patients must have stage cT1c - cT4a-d disease.
In patients with multifocal or multicentric breast cancer, the largest lesion should be measured.
Centrally confirmed ER-negative and PR-negative status. Central pathology includes also assessment of HER2, Ki-67, TIL and RANK status on core biopsy. ER/PR negative is defined as ≤1% stained cells and HER2-positive is defined as IHC 3+ or in-situ hybridization (ISH) and according to ASCO-CAP guidelines as of 2013. LPBC (lymphocyte predominant breast cancer) is defined as more than 50% stromal tumour infiltrating lymphocytes. Formalin-fixed, paraffin-embedded (FFPE) breast tissue from core biopsy has therefore to be sent to the GBG central pathology laboratory prior to randomization.

Key exclusion criteria (11 listed)

Patients with stages cT1a, cT1b, or any M1.
Prior chemotherapy for any malignancy.
Prior radiation therapy for breast cancer.
History of disease with influence on bone metabolism, such as osteoporosis, Paget's disease of bone, primary hyperparathyroidism requiring treatment at the time of randomization or considered likely to become necessary within the subsequent six months.
Use of bisphosphonates or denosumab within the past 1 year.

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
DenosumabAlso: Human monoclonal IgG2 antibodyDenosumab 120 mg every 4 weeks for 6 cycles	Drug	Denosumab
nab-PaclitaxelAlso: Abraxanenab-paclitaxel 125 mg/m² weekly for 12 weeks or at day 1,8 q22 for 4 cycles (12 weeks)	Drug	nab-Paclitaxel weekly, nab-paclitaxel 2 of 3 weeks
EpirubicinAlso: FarmorubicinEpirubicin 90 mg/m² every 2 or 3 weeks for 4 times	Drug	EC every two weeks or every three weeks
CyclophosphamideAlso: EndoxanCyclophosphamide 600 mg/m² every 2 or 3 weeks for 4 times	Drug	EC every two weeks or every three weeks
CarboplatinAlso: Diamminplatin(II)-cyclobutan-1,1-dicarboxylatCarboplatin AUC 2 weekly in parallel to nab-Paclitaxel	Drug	nab-Paclitaxel weekly, nab-paclitaxel 2 of 3 weeks
TrastuzumabAlso: HerceptinTrastuzumab 6 (8) mg/kg every 3 weeks simultaneously to all chemotherapy cycles	Drug	EC every two weeks or every three weeks, nab-Paclitaxel weekly, nab-paclitaxel 2 of 3 weeks
PertuzumabAlso: PerjetaPertuzumab 420 (840) mg every 3 weeks simultaneously to all chemotherapy cycles	Drug	EC every two weeks or every three weeks, nab-Paclitaxel weekly, nab-paclitaxel 2 of 3 weeks

Primary outcome

pcR rates of neoadjuvant treatment with or without denosumab in addition to nab-paclitaxel and EC.
Time frame: 24 weeks
pcR (ypT0 ypN0) rates of nab-Paclitaxel weekly for 12 weeks or 2 of 3 weeks for 12 weeks
Time frame: 12 weeks

2 secondary outcomes

To test for interaction of denosumab treatment with RANK expression.
Time frame: 24 weeks
To assess the pCR rates per arm for both randomizations separately for TNBC and HR-/HER2+ tumors.
Time frame: 24 weeks

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 38979716Adams A, Jakob T, Huth A, Monsef I, Ernst M, Kopp M, Caro-Valenzuela J, Wockel A, Skoetz N. Bone-modifying agents for reducing bone loss in women with early and locally advanced breast cancer: a network meta-analysis. Cochrane Database Syst Rev. 2024 Jul 9;7(7):CD013451. doi: 10.1002/14651858.CD013451.pub2.
Derived from this study: PubMed 35588050Blohmer JU, Link T, Reinisch M, Just M, Untch M, Stotzer O, Fasching PA, Schneeweiss A, Wimberger P, Seiler S, Huober J, Thill M, Jackisch C, Rhiem K, Solbach C, Hanusch C, Seither F, Denkert C, Engels K, Nekljudova V, Loibl S; GBG and AGO-B. Effect of Denosumab Added to 2 Different nab-Paclitaxel Regimens as Neoadjuvant Therapy in Patients With Primary Breast Cancer: The GeparX 2 x 2 Randomized Clinical Trial. JAMA Oncol. 2022 Jul 1;8(7):1010-1018. doi: 10.1001/jamaoncol.2022.1059.
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.
Individual participant dataSharing planned: No

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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.

Jens Uwe Blohmer, MD principal investigator

Charite Campus Mitte

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Denosumab, nab-Paclitaxel and Epirubicin in people with Breast Cancer Female NOS and Tubular Breast Cancer Stage II, 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 5 inclusion and 11 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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?

pcR rates of neoadjuvant treatment with or without denosumab in addition to nab-paclitaxel and EC. (time frame: 24 weeks). The study lists 2 primary outcomes in all. 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 NCT02682693, which also lists 3 linked publications.

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.